CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma

The Efficacy and Safety of CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma: a Randomized, Double-blind, Double Dummy, Multicenter Study

This randomized, double blind, phase 2/3 study is aimed to evaluate the efficacy and safety of CM082 in combination with everolimus in Chinese patients with advanced renal cell carcinoma. The primary endpoint is progression-free survival.

Study Overview

• Status: Unknown
• Conditions: Renal Cell Cancer Metastatic
• Intervention / Treatment: Drug: CM082 combined with everolimus; Drug: CM082; Drug: Everolimus

• Study Type: Interventional
• Enrollment (Anticipated): 390
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma
• Progressed on at least one standard therapy with VEGFR TKI
• Measurable disease per Recist v1.1
• Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
• Life expectancy of at least 12 weeks
• Adequate organ functions, and meet the following requirements:

Bone marrow: ANC ≥1.5*109/L (1500/mm3), platelet ≥100*109/L, and hemoglobin ≥9 g/dL Liver: Total bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤5x the upper limit of normal with liver involvement Kidney: Creatinine ≤ 1.25 x ULN, urine protein <1+ Heart: LVEF ≥ 50%

• Willingness and ability to comply with trial and follow-up procedures
• Ability to understand the nature of this trial and give written informed consent

Exclusion Criteria:

• Currently receiving anti-cancer treatment; currently or previously have received 2 or more systemic anti-cancer treatment
• Other tumors in addition to renal cell carcinoma
• Females who are pregnant or breastfeeding
• Known hypersensitivities to CM082 or everolimus
• Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol
• Patients with known central nervous system (CNS) metastases
• Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 or everolimus
• Any active infection
• Drug or alcohol abuser

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Everolimus	Drug: Everolimus; Everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for CM082 (2 tablets) taken orally once a day on 28-day cycles; Other Names: Affinitor
EXPERIMENTAL: CM082 combined with everolimus	Drug: CM082 combined with everolimus; CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles; Other Names: Affinitor; X-82
EXPERIMENTAL: CM082	Drug: CM082; CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for everolimus (2 tablets) taken orally once a day on 28-day cycles; Other Names: X-82

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The internal between the date of randomization and the date of death	36 months
Objective response rate	The percentage of patients with tumor response in overall population	8 weeks

Collaborators and Investigators

• Sponsor: AnewPharma
• Investigators: Study Chair: Jun Guo, MD, Peking University Cancer Hospital & Institute

Publications and helpful links

General Publications

• Sheng X, Yan X, Chi Z, Cui C, Si L, Tang B, Li S, Mao L, Lian B, Wang X, Bai X, Zhou L, Kong Y, Dai J, Ding L, Mao L, Guo J. Phase 1 trial of vorolanib (CM082) in combination with everolimus in patients with advanced clear-cell renal cell carcinoma. EBioMedicine. 2020 May;55:102755. doi: 10.1016/j.ebiom.2020.102755. Epub 2020 Apr 23.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 16, 2016
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (ACTUAL): March 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protein Kinase Inhibitors; Everolimus; Vorolanib
• Other Study ID Numbers: CM082-CA-Ⅱ-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No