Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma

April 8, 2024 updated by: Alliance for Clinical Trials in Oncology

Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma

This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the percentage of patients with potentially resectable non-epithelioid mesothelioma who are able to proceed with surgery after neoadjuvant ipilimumab and nivolumab.

II. To determine the progression-free survival rate at 12 months after the initiation of neoadjuvant ipilimumab and nivolumab.

SECONDARY OBJECTIVES:

I. To determine the rate of intra-operative or post-operative complications following neoadjuvant immunotherapy.

II. Best response per modified pleural Response Evaluation Criteria in Solid Tumors (RECIST).

III. Major pathologic response rate. IV. Time to recurrence after surgery.

EXPLORATORY OBJECTIVES:

I. To evaluate the association between the change in peripheral T cell clonality relative to baseline and treatment response.

II. To evaluate the association between PD-L1 expression at baseline and treatment response.

III. To evaluate whether a novel mesothelioma immune signature identified by Dr. Mansfield's laboratory is predictive of response.

OUTLINE:

Patients receive nivolumab intravenously (IV), ipilimumab IV, and may undergo surgery on study. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and positron emission tomography (PET) throughout the trial.

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Kingman, Arizona, United States, 86401
        • Recruiting
        • Kingman Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Hospital in Arizona
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Aaron S. Mansfield
      • Scottsdale, Arizona, United States, 85259
        • Active, not recruiting
        • Mayo Clinic in Arizona
    • California
      • Arroyo Grande, California, United States, 93420
        • Recruiting
        • PCR Oncology
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • Delaware
      • Frankford, Delaware, United States, 19945
        • Recruiting
        • Beebe South Coastal Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Lewes, Delaware, United States, 19958
        • Recruiting
        • Beebe Medical Center
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Suspended
        • Delaware Clinical and Laboratory Physicians PA
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care Health System-Christiana Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Wilmington, Delaware, United States, 19801
        • Recruiting
        • Christiana Care Health System-Wilmington Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Aaron S. Mansfield
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush - Copley Medical Center
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Hedy L. Kindler
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Young Kwang Chae
        • Contact:
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Principal Investigator:
          • Young Kwang Chae
        • Contact:
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Principal Investigator:
          • Young Kwang Chae
        • Contact:
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • Northwestern Medicine Glenview Outpatient Center
        • Principal Investigator:
          • Young Kwang Chae
        • Contact:
          • Site Public Contact
          • Phone Number: 312-695-1102
      • Grayslake, Illinois, United States, 60030
        • Recruiting
        • Northwestern Medicine Grayslake Outpatient Center
        • Principal Investigator:
          • Young Kwang Chae
        • Contact:
          • Site Public Contact
          • Phone Number: 312-695-1102
      • Lake Forest, Illinois, United States, 60045
        • Recruiting
        • Northwestern Medicine Lake Forest Hospital
        • Principal Investigator:
          • Young Kwang Chae
        • Contact:
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Orland Park, Illinois, United States, 60462
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Principal Investigator:
          • Young Kwang Chae
        • Contact:
      • Yorkville, Illinois, United States, 60560
        • Recruiting
        • Rush-Copley Healthcare Center
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Recruiting
        • Christiana Care - Union Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Aaron S. Mansfield
    • Nevada
      • Carson City, Nevada, United States, 89703
        • Recruiting
        • Carson Tahoe Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Cancer and Blood Specialists-Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • OptumCare Cancer Care at Seven Hills
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • GenesisCare USA - Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Urology - Green Valley
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Urology - Pebble
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Urology Specialists of Nevada - Green Valley
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Henderson, Nevada, United States, 89052
        • Suspended
        • Las Vegas Cancer Center-Henderson
      • Las Vegas, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Urology - Pecos
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • OptumCare Cancer Care at Charleston
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • University Medical Center of Southern Nevada
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89103
        • Recruiting
        • Hope Cancer Care of Nevada
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Radiation Oncology Centers of Nevada Central
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Urology Specialists of Nevada - Central
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • GenesisCare USA - Las Vegas
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Sunrise Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Las Vegas Prostate Cancer Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Las Vegas Urology - Sunset
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Urology Specialists of Nevada - Southwest
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • Radiation Oncology Centers of Nevada Southeast
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Ann M Wierman MD LTD
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Northwest
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • GenesisCare USA - Vegas Tenaya
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Las Vegas Urology - Cathedral Rock
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Las Vegas Urology - Smoke Ranch
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • OptumCare Cancer Care at MountainView
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Urology Specialists of Nevada - Northwest
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89135
        • Recruiting
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Town Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Summerlin
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Summerlin Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • GenesisCare USA - Fort Apache
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • OptumCare Cancer Care at Fort Apache
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Central Valley
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • University Cancer Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148-2405
        • Suspended
        • Las Vegas Cancer Center-Medical Center
      • Pahrump, Nevada, United States, 89048
        • Recruiting
        • Hope Cancer Care of Nevada-Pahrump
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89503
        • Recruiting
        • Saint Mary's Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89509
        • Recruiting
        • Radiation Oncology Associates
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
        • Principal Investigator:
          • Jeffrey M. Clarke
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Recruiting
        • Christiana Care Health System-Concord Health Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Washington
      • Bellevue, Washington, United States, 98004
        • Suspended
        • Overlake Medical Center
      • Renton, Washington, United States, 98055
        • Recruiting
        • Valley Medical Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Yakima, Washington, United States, 98902
        • Recruiting
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
        • Principal Investigator:
          • John A. Ellerton
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sarcomatoid or sarcomatoid-dominant (> 50%) biphasic, pleural mesothelioma
  • Stage: I-IIIA disease per Union for International Cancer Control (UICC) TNM Classification of Malignant Tumours 8th edition
  • Measurable disease or non-measurable disease as defined
  • No prior treatment which would be considered treatment for the primary neoplasm or impact the primary endpoint
  • No treatment with hormones or other chemotherapeutic agents except for hormones administered for non-disease-related conditions (e.g., insulin for diabetes and or hormonal therapy for breast, prostate cancer etc.)

  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown

    * Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required

  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky >= 60%
  • Absolute neutrophil count (ANC) >= 1,000/mm^3
  • Leukocytes >= 2,000/mm^3
  • Platelet count >= 100,000/mm^3
  • Creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance >= 40 mL/min
  • Total bilirubin =<1.5 x ULN, except patients with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dl
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN
  • Alkaline (alk) phosphatase (phos) =< 3.0 x ULN
  • No active, known or suspected autoimmune disease except for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • No active systemic infection requiring therapy, as well as positive tests for hepatitis B surface antigen or hepatitis C antibody
  • No history of any other condition that may require the initiation of anti-tumor necrosis factor alpha (TNFalpha) therapies or other immunosuppressant medications during the study
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • 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 Classification. To be eligible for this trial, patients should be class 2B or better
  • 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 are eligible for this trial
  • STEP 2 ELIGIBILITY CRITERIA: Completion of at least 1 cycle of treatment and not have an unresolved adverse event that would preclude surgery
  • STEP 2 ELIGIBILITY CRITERIA: No evidence of progression that would preclude resection
  • STEP 2 ELIGIBILITY CRITERIA: ECOG performance status =< 2 or Karnofsky >= 60%
  • STEP 2 ELIGIBILITY CRITERIA: Predicted forced expiratory volume in 1 second (FEV1) > 35% and postoperative predicted diffusion capacity of the lung for carbon monoxide (DLCO) > 35%
  • STEP 2 ELIGIBILITY CRITERIA: Registration to step 2 no less than 21 days and no more than 90 days after the last dose of neoadjuvant therapy

Exclusion Criteria:

  • No patients deemed to be unresectable or poor surgical candidates
  • No patients with chest wall invasion, peritoneal spread, contralateral pleural involvement, mediastinal organ involvement, vertebral involvement, or metastases to contralateral intrathoracic lymph nodes, or any supraclavicular nodes
  • No patients with a history of symptomatic interstitial lung disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (nivolumab, ipilimumab, surgery)
Patients receive nivolumab IV, ipilimumab IV, and may undergo surgery on study. Patients also undergo CT or MRI and PET throughout the trial.
Biological: Nivolumab
Given IV
Other Names:
  • 946414-94-4, BMS-936558, CMAB819, MDX-1106, NIVO, NIVOLUMAB, Nivolumab, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
Biological: Ipilimumab
Given IV
Other Names:
  • 477202-00-9, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, IPILIMUMAB, ipilimumab, Ipilimumab Biosimilar CS1002, MDX-010, MDX-010, MDX-CTLA4, Yervoy
Procedure: Positron Emission Tomography
Undergo PET
Other Names:
  • Medical Imaging, PET, Pet Scan
Procedure: Surgical Procedure
Undergo surgery
Procedure: Computed Tomography
undergo CT
Other Names:
  • CAT, CAT Scan,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery Rate
Time Frame: immediately after the completion of neoadjuvant immunotherapy and surgery
The rate of surgery after neoadjuvant immunotherapy among the feasibility analysis population as well as the 80% and 95% exact Clopper-Pearson confidence intervals will be estimated.
immediately after the completion of neoadjuvant immunotherapy and surgery
Progression free survival (PFS)
Time Frame: At 12 months after initiation of neoadjuvant immunotherapy
PFS will be determined per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The rate of PFS at 12 months after the initiation of neoadjuvant immunotherapy among the feasibility and efficacy analysis population as well as the 80% and 95% exact Clopper-Pearson confidence intervals will be estimated.
At 12 months after initiation of neoadjuvant immunotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 5 years
The type of adverse events, the frequency of each type and its grade will be summarized. The frequency and the percentage of severe adverse events will be presented in bar charts over treatment phase (neoadjuvant immunotherapy, surgery) to describe the change of adverse event or complication severity over time. The rates of the pre-operative or post-operative complications (within 30 days of surgery) will be estimated with its exact 95% confidence interval.
Up to 5 years
Objective response rate
Time Frame: Up to 5 years
Will be determined per modified RECIST. Response rate will be reported with 95% exact confidence interval.
Up to 5 years
Major pathologic response
Time Frame: Up to 5 years
Defined as =< 10% residual viable tumor in the resected lung and lymph node tissue. Response rates will be reported with 95% exact confidence interval.
Up to 5 years
Time to recurrence
Time Frame: Time from surgery to disease relapse, progression, or second tumor, whichever occurs first, assessed up to 5 years
Time to recurrence will be estimated among those patients who receive surgery and will be characterized by estimating cumulative incidence function and conducting cause-specific and subdistribution hazard regression.
Time from surgery to disease relapse, progression, or second tumor, whichever occurs first, assessed up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers
Time Frame: Up to 5 years
The association of pre-treatment and on-treatment biomarkers in peripheral blood and in tumor tissues with response and time to recurrence, will be evaluated univariately through Chi-square test or log-rank test and through logistic regression model or Cox regression model with other prognostic factors adjusted.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2023

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

December 9, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A082101
  • U10CA180821 (U.S. NIH Grant/Contract)
  • NCI-2022-09320 (Other Identifier: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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