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在患有晚期肾上腺皮质癌的青少年和成年人中，测试将抗癌药Cabozantinib添加到免疫疗法药物Cemiplimab（REGN2810）中

2026年11月5日 更新者：National Cancer Institute (NCI)

Cabozantinib与cemiplimab（Cabo-Cemiplimab）与Cabozantinib结合的II期研究

This phase II trial compares the effect of giving cabozantinib with or without cemiplimab in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), and that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib with cemiplimab may kill more tumor cells in patients with locally advanced unresectable or recurrent/metastatic adrenocortical cancer.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

PRIMARY OBJECTIVE:

I. To determine whether the combination of cabozantinib plus cemiplimab (REGN2810) (Cabo-Cemiplimab [REGN2810]) improves progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 relative to cabozantinib alone in patients with locally advanced unresectable or recurrent/metastatic advanced adrenocortical cancer.

SECONDARY OBJECTIVES:

I. To assess tolerability and adverse events of Cabo-Cemiplimab (REGN2810) in advanced adrenocortical cancer (ACC) patients.

II. To assess objective response rate as per RECIST v 1.1. III. To assess duration of objective response, time to progression (TTP), and overall survival (OS) in ACC patients receiving Cabo-Cemiplimab (REGN2810).

EXPLORATORY OBJECTIVE:

I. To assess PFS from re-registration (per RECIST 1.1) and OS for patients who crossover to receive Cabo-Cemiplimab after progressing on cabozantinib alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive cabozantinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) and blood sample collection throughout the study. Upon disease progression, patients may elect to crossover to receive combination therapy on Arm B.

ARM B: Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1 and cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 12 weeks until disease progression and then every 6 months for 4 years post-registration.

研究类型

介入性

注册 (估计的)

48

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85054
        • 招聘中
        • Mayo Clinic Hospital in Arizona
        • 接触：
          • Site Public Contact
          • 电话号码：855-776-0015
        • 首席研究员：
          • Julie E. Hallanger Johnson
    • California
      • La Jolla、California、美国、92093
        • 招聘中
        • UC San Diego Moores Cancer Center
        • 接触：
        • 首席研究员：
          • Yu-Wei Chen
      • Madera、California、美国、93636
        • 招聘中
        • Valley Children's Hospital
        • 接触：
        • 首席研究员：
          • Ruetima Titapiwatanakun
    • Colorado
      • Aurora、Colorado、美国、80045
        • 招聘中
        • UCHealth University of Colorado Hospital
        • 首席研究员：
          • Laura Graham
        • 接触：
          • Site Public Contact
          • 电话号码：720-848-0650
    • Florida
      • Jacksonville、Florida、美国、32224-9980
        • 招聘中
        • Mayo Clinic in Florida
        • 接触：
          • Site Public Contact
          • 电话号码：855-776-0015
        • 首席研究员：
          • Julie E. Hallanger Johnson
    • Illinois
      • Chicago、Illinois、美国、60611
        • 招聘中
        • Lurie Children's Hospital-Chicago
        • 接触：
          • Site Public Contact
          • 电话号码：773-880-4562
        • 首席研究员：
          • Elizabeth A. Sokol
      • Chicago、Illinois、美国、60611
        • 招聘中
        • Northwestern University
        • 首席研究员：
          • Mary F. Mulcahy
        • 接触：
      • Danville、Illinois、美国、61832
        • 招聘中
        • Carle at The Riverfront
        • 首席研究员：
          • Priyank P. Patel
        • 接触：
      • DeKalb、Illinois、美国、60115
        • 招聘中
        • Northwestern Medicine Cancer Center Kishwaukee
        • 首席研究员：
          • Mary F. Mulcahy
        • 接触：
      • Effingham、Illinois、美国、62401
        • 招聘中
        • Carle Physician Group-Effingham
        • 接触：
        • 首席研究员：
          • Priyank P. Patel
      • Geneva、Illinois、美国、60134
        • 招聘中
        • Northwestern Medicine Cancer Center Delnor
        • 首席研究员：
          • Mary F. Mulcahy
        • 接触：
      • Glenview、Illinois、美国、60026
        • 招聘中
        • Northwestern Medicine Glenview Outpatient Center
        • 首席研究员：
          • Mary F. Mulcahy
        • 接触：
          • Site Public Contact
          • 电话号码：312-695-1102
      • Grayslake、Illinois、美国、60030
        • 招聘中
        • Northwestern Medicine Grayslake Outpatient Center
        • 首席研究员：
          • Mary F. Mulcahy
        • 接触：
          • Site Public Contact
          • 电话号码：312-695-1102
      • Lake Forest、Illinois、美国、60045
        • 招聘中
        • Northwestern Medicine Lake Forest Hospital
        • 首席研究员：
          • Mary F. Mulcahy
        • 接触：
      • Mattoon、Illinois、美国、61938
        • 招聘中
        • Carle Physician Group-Mattoon/Charleston
        • 接触：
        • 首席研究员：
          • Priyank P. Patel
      • Normal、Illinois、美国、61761
        • 招聘中
        • Carle BroMenn Medical Center
        • 首席研究员：
          • Priyank P. Patel
        • 接触：
      • Normal、Illinois、美国、61761
        • 招聘中
        • Carle Cancer Institute Normal
        • 首席研究员：
          • Priyank P. Patel
        • 接触：
      • Oak Brook、Illinois、美国、60523
      • Orland Park、Illinois、美国、60462
      • Shiloh、Illinois、美国、62269
        • 招聘中
        • Memorial Hospital East
        • 接触：
        • 首席研究员：
          • Nikolaos Trikalinos
      • Urbana、Illinois、美国、61801
        • 招聘中
        • Carle Cancer Center
        • 接触：
        • 首席研究员：
          • Priyank P. Patel
      • Warrenville、Illinois、美国、60555
        • 招聘中
        • Northwestern Medicine Cancer Center Warrenville
        • 首席研究员：
          • Mary F. Mulcahy
        • 接触：
    • Iowa
      • Ankeny、Iowa、美国、50023
        • 招聘中
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • 接触：
          • Site Public Contact
          • 电话号码：515-241-3305
        • 首席研究员：
          • Seema Harichand-Herdt
      • Carroll、Iowa、美国、51401
        • 招聘中
        • Saint Anthony Regional Hospital
        • 接触：
        • 首席研究员：
          • Seema Harichand-Herdt
      • Clive、Iowa、美国、50325
        • 招聘中
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • 接触：
          • Site Public Contact
          • 电话号码：515-241-3305
        • 首席研究员：
          • Seema Harichand-Herdt
      • Des Moines、Iowa、美国、50314
        • 招聘中
        • Broadlawns Medical Center
        • 接触：
          • Site Public Contact
          • 电话号码：515-282-2200
        • 首席研究员：
          • Seema Harichand-Herdt
      • Des Moines、Iowa、美国、50314
        • 招聘中
        • Mercy Medical Center - Des Moines
        • 接触：
          • Site Public Contact
          • 电话号码：515-241-3305
        • 首席研究员：
          • Richard L. Deming
      • Des Moines、Iowa、美国、50309
        • 招聘中
        • Iowa Methodist Medical Center
        • 接触：
          • Site Public Contact
          • 电话号码：515-241-6727
        • 首席研究员：
          • Seema Harichand-Herdt
      • Des Moines、Iowa、美国、50309
        • 招聘中
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • 接触：
          • Site Public Contact
          • 电话号码：515-241-3305
        • 首席研究员：
          • Seema Harichand-Herdt
      • Des Moines、Iowa、美国、50314
        • 招聘中
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • 接触：
          • Site Public Contact
          • 电话号码：515-241-3305
        • 首席研究员：
          • Seema Harichand-Herdt
      • Fort Dodge、Iowa、美国、50501
        • 招聘中
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
        • 首席研究员：
          • Seema Harichand-Herdt
        • 接触：
      • Waukee、Iowa、美国、50263
        • 招聘中
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • 接触：
          • Site Public Contact
          • 电话号码：515-241-3305
        • 首席研究员：
          • Seema Harichand-Herdt
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Dana-Farber Cancer Institute
        • 首席研究员：
          • Stephanie A. Berg
        • 接触：
          • Site Public Contact
          • 电话号码：877-442-3324
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • 招聘中
        • University of Michigan Rogel Cancer Center
        • 首席研究员：
          • Francis P. Worden
        • 接触：
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Mayo Clinic in Rochester
        • 接触：
          • Site Public Contact
          • 电话号码：855-776-0015
        • 首席研究员：
          • Julie E. Hallanger Johnson
    • Missouri
      • City of Saint Peters、Missouri、美国、63376
        • 招聘中
        • Siteman Cancer Center at Saint Peters Hospital
        • 接触：
        • 首席研究员：
          • Nikolaos Trikalinos
      • Creve Coeur、Missouri、美国、63141
        • 招聘中
        • Siteman Cancer Center at West County Hospital
        • 接触：
        • 首席研究员：
          • Nikolaos Trikalinos
      • Kansas City、Missouri、美国、64108
        • 招聘中
        • Children's Mercy Hospitals and Clinics
        • 首席研究员：
          • Keith J. August
        • 接触：
      • Springfield、Missouri、美国、65807
        • 招聘中
        • CoxHealth South Hospital
        • 首席研究员：
          • Jay W. Carlson
        • 接触：
          • Site Public Contact
          • 电话号码：417-269-4520
      • St Louis、Missouri、美国、63110
        • 招聘中
        • Washington University School of Medicine
        • 接触：
        • 首席研究员：
          • Nikolaos Trikalinos
      • St Louis、Missouri、美国、63129
        • 招聘中
        • Siteman Cancer Center-South County
        • 接触：
        • 首席研究员：
          • Nikolaos Trikalinos
      • St Louis、Missouri、美国、63136
        • 招聘中
        • Siteman Cancer Center at Christian Hospital
        • 接触：
        • 首席研究员：
          • Nikolaos Trikalinos
    • Nebraska
      • Bellevue、Nebraska、美国、68123
        • 招聘中
        • Nebraska Medicine-Bellevue
        • 接触：
        • 首席研究员：
          • Apar Kishor Ganti
      • Omaha、Nebraska、美国、68198
        • 招聘中
        • University of Nebraska Medical Center
        • 接触：
        • 首席研究员：
          • Apar Kishor Ganti
      • Omaha、Nebraska、美国、68118
        • 招聘中
        • Nebraska Medicine-Village Pointe
        • 接触：
          • Site Public Contact
          • 电话号码：402-559-5600
        • 首席研究员：
          • Apar Kishor Ganti
    • New Jersey
      • Basking Ridge、New Jersey、美国、07920
        • 招聘中
        • Memorial Sloan Kettering Basking Ridge
        • 接触：
          • Site Public Contact
          • 电话号码：212-639-7592
        • 首席研究员：
          • Nitya P. Raj
      • Middletown、New Jersey、美国、07748
        • 招聘中
        • Memorial Sloan Kettering Monmouth
        • 接触：
          • Site Public Contact
          • 电话号码：212-639-7592
        • 首席研究员：
          • Nitya P. Raj
      • Montvale、New Jersey、美国、07645
        • 招聘中
        • Memorial Sloan Kettering Bergen
        • 接触：
          • Site Public Contact
          • 电话号码：212-639-7592
        • 首席研究员：
          • Nitya P. Raj
    • New York
      • Commack、New York、美国、11725
        • 招聘中
        • Memorial Sloan Kettering Commack
        • 接触：
          • Site Public Contact
          • 电话号码：212-639-7592
        • 首席研究员：
          • Nitya P. Raj
      • Harrison、New York、美国、10604
        • 招聘中
        • Memorial Sloan Kettering Westchester
        • 接触：
          • Site Public Contact
          • 电话号码：212-639-7592
        • 首席研究员：
          • Nitya P. Raj
      • New York、New York、美国、10065
        • 招聘中
        • Memorial Sloan Kettering Cancer Center
        • 接触：
          • Site Public Contact
          • 电话号码：212-639-7592
        • 首席研究员：
          • Nitya P. Raj
      • Uniondale、New York、美国、11553
        • 招聘中
        • Memorial Sloan Kettering Nassau
        • 接触：
          • Site Public Contact
          • 电话号码：212-639-7592
        • 首席研究员：
          • Nitya P. Raj
    • North Carolina
      • Cary、North Carolina、美国、27518
        • 暂停
        • Duke Cancer Center Cary
      • Durham、North Carolina、美国、27710
        • 招聘中
        • Duke University Medical Center
        • 接触：
          • Site Public Contact
          • 电话号码：888-275-3853
        • 首席研究员：
          • Diane L. Reidy-lagunes
      • Raleigh、North Carolina、美国、27609
        • 招聘中
        • Duke Cancer Center Raleigh
        • 接触：
        • 首席研究员：
          • Diane L. Reidy-lagunes
    • Ohio
      • Columbus、Ohio、美国、43210
        • 招聘中
        • Ohio State University Comprehensive Cancer Center
        • 接触：
        • 首席研究员：
          • Bhavana Konda
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • 招聘中
        • University of Oklahoma Health Sciences Center
        • 接触：
        • 首席研究员：
          • Adanma Anji Ayanambakkam Attanathi
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15224
        • 招聘中
        • Children's Hospital of Pittsburgh of UPMC
        • 接触：
        • 首席研究员：
          • Brittani K. Seynnaeve
    • South Carolina
      • Boiling Springs、South Carolina、美国、29316
        • 招聘中
        • Prisma Health Cancer Institute - Spartanburg
        • 首席研究员：
          • Aniket Saha
        • 接触：
      • Columbia、South Carolina、美国、29203
        • 招聘中
        • Prisma Health Richland Hospital
        • 首席研究员：
          • Aniket Saha
        • 接触：
      • Easley、South Carolina、美国、29640
        • 招聘中
        • Prisma Health Cancer Institute - Easley
        • 首席研究员：
          • Aniket Saha
        • 接触：
      • Greenville、South Carolina、美国、29605
        • 招聘中
        • BI-LO Charities Children's Cancer Center
        • 首席研究员：
          • Aniket Saha
        • 接触：
      • Greenville、South Carolina、美国、29605
        • 招聘中
        • Prisma Health Cancer Institute - Faris
        • 首席研究员：
          • Aniket Saha
        • 接触：
      • Greenville、South Carolina、美国、29605
        • 招聘中
        • Prisma Health Cancer Institute - Butternut
        • 首席研究员：
          • Aniket Saha
        • 接触：
      • Greenville、South Carolina、美国、29615
        • 招聘中
        • Prisma Health Cancer Institute - Eastside
        • 首席研究员：
          • Aniket Saha
        • 接触：
      • Greer、South Carolina、美国、29650
        • 招聘中
        • Prisma Health Cancer Institute - Greer
        • 首席研究员：
          • Aniket Saha
        • 接触：
      • Seneca、South Carolina、美国、29672
        • 招聘中
        • Prisma Health Cancer Institute - Seneca
        • 首席研究员：
          • Aniket Saha
        • 接触：
    • Tennessee
      • Memphis、Tennessee、美国、38105
        • 招聘中
        • Saint Jude Children's Research Hospital
        • 接触：
        • 首席研究员：
          • Catherine G. Lam
    • Texas
      • Austin、Texas、美国、78723
      • Dallas、Texas、美国、75390
        • 招聘中
        • UT Southwestern/Simmons Cancer Center-Dallas
        • 接触：
        • 首席研究员：
          • Suzanne M. Cole
      • Dallas、Texas、美国、75235
        • 招聘中
        • Parkland Memorial Hospital
        • 接触：
        • 首席研究员：
          • Suzanne M. Cole
      • Dallas、Texas、美国、75237
        • 招聘中
        • UT Southwestern Simmons Cancer Center - RedBird
        • 首席研究员：
          • Suzanne M. Cole
        • 接触：
      • Fort Worth、Texas、美国、76104
      • Fort Worth、Texas、美国、76104
        • 招聘中
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • 接触：
        • 首席研究员：
          • Suzanne M. Cole
      • Richardson、Texas、美国、75080
        • 招聘中
        • UT Southwestern Clinical Center at Richardson/Plano
        • 接触：
        • 首席研究员：
          • Suzanne M. Cole
      • San Antonio、Texas、美国、78207
        • 招聘中
        • Children's Hospital of San Antonio
        • 接触：
        • 首席研究员：
          • Julie Voeller
      • San Antonio、Texas、美国、78229
        • 招聘中
        • University of Texas Health Science Center at San Antonio
        • 接触：
        • 首席研究员：
          • Aaron J. Sugalski
    • Virginia
      • Richmond、Virginia、美国、23235
        • 招聘中
        • VCU Massey Cancer Center at Stony Point
        • 接触：
        • 首席研究员：
          • Asit K. Paul
      • Richmond、Virginia、美国、23298
        • 招聘中
        • VCU Massey Comprehensive Cancer Center
        • 首席研究员：
          • Asit K. Paul
        • 接触：
    • Washington
      • Seattle、Washington、美国、98195
        • 招聘中
        • University of Washington Medical Center - Montlake
        • 接触：
          • Site Public Contact
          • 电话号码：800-804-8824
        • 首席研究员：
          • Keith D. Eaton
      • Seattle、Washington、美国、98109
        • 招聘中
        • Fred Hutchinson Cancer Center
        • 接触：
          • Site Public Contact
          • 电话号码：800-804-8824
        • 首席研究员：
          • Keith D. Eaton

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • STEP 1: Patients must have documented histologically or cytologically confirmed adrenocortical carcinoma

  • STEP 1: Locally advanced unresectable or recurrent/metastatic disease

  • STEP 1: Evaluable disease as defined by RECIST v 1.1

  • STEP 1: Up to 3 prior lines of systemic therapy will be allowed in the unresectable/recurrent/metastatic setting. Treatment naïve patients will be allowed.

    • Note: Combination etoposide, doxorubicin, cisplatin, and mitotane (EDP-M) is considered 1 line of therapy. For patients who received mitotane ≤ 6 months prior to registration, mitotane should be discontinued 28 days prior to study registration AND a mitotane level must be documented to be < 2 mg/L prior to registration. Patients who have received mitotane within 6 months of enrollment and who have mitotane levels ≥ 2 mg/L will not be eligible to enroll

  • STEP 1: No prior treatment with cabozantinib or other cMET inhibitors, or anti-CTLA-4, or anti-PD-1/PD-L1 therapy

  • STEP 1: Prior external beam radiation therapy (any area radiated within a month prior to study registration cannot be used as an index lesion and only growth outside of the radiation field can be considered for disease progression), systemic cytotoxic chemotherapy, targeted therapies will be allowed, as long as not administered within 14 days before study registration, and provided any acute treatment-related associated toxicities have recovered to ≤ grade 1 except for alopecia, peripheral neuropathy or other residual toxicities that are not deemed clinically significant

  • STEP 1: Potential trial participants should have recovered from clinically significant adverse events, and wound healing is clinically adequate of their most recent therapy/intervention prior to enrollment

  • STEP 1: Age 12 years and above; and BSA ≥ 1.2m^2

  • STEP 1:

    • Eastern Cooperative Oncology Group (ECOG) performance 0 - 2 (age 18 and above); or
    • Patients 12 to <16 years of age will be assessed by the Lansky scale and should have a score ≥ 50; or
    • Patients ≥ 16 to <18 years of age will be assessed by the Karnofsky scale, and should have a score ≥ 50

  • STEP 1: Absolute neutrophil count (ANC) ≥ 1,000/mcL without colony stimulating factor support within 2 weeks prior

    • Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory

  • STEP 1: Platelet count ≥ 100,000/mcL

    • Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory

  • STEP 1: Hemoglobin ≥ 8 g/dL

    • Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory

  • STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

    • For patients with known Gilbert's disease, bilirubin ≤ 3 mg/dL

  • STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x upper limit of normal (ULN)

  • STEP 1: Random Urine Creatinine Ratio (UPCR) ≤ 1 mg/mg

  • STEP 1: Calculated (Calc.) creatinine clearance ≥ 30 mL/min

  • STEP 1: Mitotane level < 2 mg/L*

    • Only applicable for patients who have received mitotane ≤ 6 months prior to registration

  • STEP 1: Must have assessment of adrenal steroid production within 3 months prior to registration as patients will be stratified based on corticosteroid production

    • Patients will be classified as corticosteroid producing if random plasma adrenocorticotropic hormone (ACTH) is < 20 pg/mL plus random serum cortisol is > 20 mcg/dL in the absence of anti-cortisol therapy. Patients already on anti-cortisol therapy will be classified as having corticosteroid producing tumors regardless of their plasma ACTH and serum cortisol levels, as these levels can be affected by anti-cortisol therapy

  • STEP 1: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects based on animal reproduction studies. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test, per institution standard, done ≤ 14 days prior to registration is required

  • STEP 1: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional within 28 days of registration. To be eligible for this trial, patients should be class II or better

  • STEP 1: No known history of congenital long QT syndrome

  • STEP 1: No known history of myocarditis

  • STEP 1: No myocardial infarction (MI) or unstable angina within 6 months of registration

  • STEP 1: No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 6 months of registration including, but not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with history of bleeding, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation

  • STEP 1: No history of gastrointestinal (GI) perforation within 6 months of registration

  • STEP 1: No known tumor with invasion into the GI tract from the outside causing increased risk of perforation or bleeding within 28 days of registration

  • STEP 1: No current radiologic or clinical evidence of pancreatitis

  • STEP 1: No history of clinically significant non-healing wounds or ulcers within 28 days of registration

  • STEP 1: No uncontrolled hypertension within 14 days of registration (defined as sustained systolic blood pressure (SBP) ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg despite optimal medical management)

  • STEP 1: No known endobronchial lesions involving the main or lobar bronchi and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage. (CT with contrast is recommended to evaluate such lesions.). No hemoptysis greater than ½ teaspoon (2.5 mL) or any other signs of pulmonary hemorrhage within the 3 months prior to registration

  • STEP 1: No history of pneumonitis

  • STEP 1: No known tumor invading or encasing any major blood vessels

  • STEP 1: No history of fracture within 28 days of registration

  • STEP 1: No known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks after major surgery (e.g., removal or biopsy of brain metastasis) before registration. Eligible patients must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment

  • STEP 1: Major surgery (e.g., laparoscopic nephrectomy, GI surgery, within 2 weeks before registration. Minor surgeries within 10 days before registration. Patients with clinically relevant ongoing complications from prior surgery are not eligible

  • STEP 1: Verbalizes the ability to swallow oral tablet formulation

  • STEP 1: No history of allergic reaction attributed to compounds of similar chemical or biological composition to cabozantinib

  • STEP 1: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen will be eligible

  • STEP 1: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial

  • STEP 1: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

  • STEP 1: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

  • STEP 1: No active autoimmune disease: or history of autoimmune disease that might recur, and which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of:

    • immune related neurologic disease,
    • multiple sclerosis,
    • autoimmune (demyelinating) neuropathy,
    • Guillain-Barre syndrome (GBS), myasthenia gravis,
    • systemic autoimmune disease such as systemic lupus erythematosus (SLE),
    • connective tissue diseases,
    • scleroderma, inflammatory bowel disease (IBD),
    • Crohn's, ulcerative colitis,
    • patients with a history of toxic epidermal necrolysis (TEN),
    • Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease,
    • Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible,
    • Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome, and psoriasis controlled with topical medication and patients with only positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible

  • STEP 1: No steroid use > 10 mg prednisone equivalents daily. A brief course of corticosteroids for prophylaxis or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as is steroid pre-medication for contrast allergy

  • STEP 1: Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study

  • STEP 1: Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

  • STEP 1: Herbal supplements and traditional Chinese medicines are not allowed

  • STEP 1: Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration. Allowed use of anticoagulants include: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, apixaban. Also use of anticoagulants is allowed in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor

  • STEP 2 (CROSSOVER): Patients must have demonstrated radiographic progression of disease on cabozantinib monotherapy (Arm A) per RECIST version 1.1 criteria

    • Patients must cross-over to Arm C within 4 weeks (+/- 1 week) after radiographic documented progression and do not need to have a repeat radiographic assessment prior to starting cabozantinib and cemiplimab (REGN2810). The progression CT may serve as eligibility for crossover and as the baseline tumor measurement

  • STEP 2 (CROSSOVER): Patients that were discontinued on cabozantinib, or currently meet criteria for discontinuation of cabozantinib due to toxicity are not eligible to cross-over.

    • Note: Patients who underwent dose reduction of cabozantinib during treatment on Arm A will not re-escalate dose at or after cross-over to Cabo-Cemiplimab (REGN2810) (Arm B)

  • STEP 2 (CROSSOVER): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done ≤ 14 days prior to re-registration is required

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm A (cabozantinib)

Patients receive cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study. Upon disease progression, patients may elect to crossover to receive combination therapy on Arm B.
程序：Biospecimen Collection

Undergo blood sample collection

其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
程序：Magnetic Resonance Imaging

Undergo MRI

其他名称：
  • 核磁共振
  • 磁共振
  • 磁共振成像扫描
  • 医学影像、磁共振/核磁共振
  • 先生
  • 磁共振成像
  • 核磁共振成像扫描
  • 核磁共振成像
  • 磁共振成像 (MRI)
  • 磁共振成像（程序）
  • 结构核磁共振
程序：Computed Tomography

Undergo CT scan

其他名称：
  • CT
  • 猫
  • 电脑扫描
  • 计算机轴向断层扫描
  • 计算机断层扫描
  • CT扫描
  • 断层扫描
  • 计算机轴向断层扫描（程序）
  • 计算机断层扫描 (CT) 扫描
  • 诊断猫扫描
  • 诊断猫扫描服务类型
药品：Cabozantinib

Given PO
实验性的：Arm B (cabozantinib and cemiplimab)

Patients receive cemiplimab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study.
程序：Biospecimen Collection

Undergo blood sample collection

其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
程序：Magnetic Resonance Imaging

Undergo MRI

其他名称：
  • 核磁共振
  • 磁共振
  • 磁共振成像扫描
  • 医学影像、磁共振/核磁共振
  • 先生
  • 磁共振成像
  • 核磁共振成像扫描
  • 核磁共振成像
  • 磁共振成像 (MRI)
  • 磁共振成像（程序）
  • 结构核磁共振
程序：Computed Tomography

Undergo CT scan

其他名称：
  • CT
  • 猫
  • 电脑扫描
  • 计算机轴向断层扫描
  • 计算机断层扫描
  • CT扫描
  • 断层扫描
  • 计算机轴向断层扫描（程序）
  • 计算机断层扫描 (CT) 扫描
  • 诊断猫扫描
  • 诊断猫扫描服务类型
药品：Cabozantinib

Given PO

生物：Cemiplimab

Given IV

其他名称：
  • REGN2810
  • Cemiplimab RWLC
  • Cemiplimab-rwlc
  • 利布塔约
  • 雷根2810
  • REGN-2810

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Progression free survival (PFS)
大体时间：From registration to either progression or death, assessed up to 4 years post-registration

Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Will be analyzed using an intention-to-treat approach. Kaplan-Meier methodology will be used to estimate the distributions for the treatment arms. The hazard ratio, median PFS, and estimated PFS rates at 5, 10 and 15 months will be estimated along with corresponding 95% confidence intervals. A one-sided log rank-test will be used to compare the PFS distributions between the two treatment arms.
From registration to either progression or death, assessed up to 4 years post-registration

次要结果测量

结果测量
措施说明
大体时间
Incidence of adverse events
大体时间：Up to 4 years post-registration

Adverse events will be recorded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 for each patient. Frequency tables and summary statistics will be used and with the appropriate methods of evaluating categorical and continuous data.
Up to 4 years post-registration
Objective response rate
大体时间：Up to 4 years post-registration

Will be assessed based on RECIST 1.1 criteria and will be summarized by treatment arm. will be calculated as the number of patients who achieve a response (partial response, complete response) divided by the total number of patients randomized to the corresponding treatment arm. A contingency table comparing treatment arms and responders to non-responders will be generated and a Fisher's exact test with a p-value cutoff of 0.05 will be used for determining whether evidence of a significant association between treatment and response is found.
Up to 4 years post-registration
Duration of response
大体时间：From first date of the patient achieving either a complete or partial response and progression (via RECIST v 1.1), assessed up to 4 years post-registration

Kaplan-Meier methodology will be used to estimate the distributions of duration of response and a log-rank test between treatment arm will be calculated with corresponding p-value.
From first date of the patient achieving either a complete or partial response and progression (via RECIST v 1.1), assessed up to 4 years post-registration
Time to progression
大体时间：From registration date and progression date, assessed up to 4 years post-registration

Kaplan-Meier methodology will be used to estimate the distributions of time to progression.
From registration date and progression date, assessed up to 4 years post-registration
Overall survival
大体时间：From registration to death, assessed up to 4 years post-registration

Kaplan-Meier methodology will be used to estimate the distributions of overall survival.
From registration to death, assessed up to 4 years post-registration

其他结果措施

结果测量
措施说明
大体时间
Median PFS for patients who cross over
大体时间：From re-registration to progression or death, assessed up to 4 years post-registration

Calculated with corresponding 95% confidence interval.
From re-registration to progression or death, assessed up to 4 years post-registration

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Cancer Institute (NCI)

调查人员

  • 首席研究员：Bhavana Konda、Alliance for Clinical Trials in Oncology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月22日

初级完成 (估计的)

2029年6月2日

研究完成 (估计的)

2029年6月2日

研究注册日期

首次提交

2025年3月26日

首先提交符合 QC 标准的

2025年3月26日

首次发布 (实际的)

2025年3月28日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NCI-2025-02021
  • U10CA180821 (美国 NIH 拨款/合同)
  • NCI-2025-02021 (注册表标识符：CTRP (Clinical Trial Reporting Program))
  • A092204 (其他标识符：CTEP)
  • A092204 (其他标识符：Alliance for Clinical Trials in Oncology)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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