Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03108131|
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Skin Squamous Cell Carcinoma Appendix Adenocarcinoma Rare Lesion Locally Advanced Malignant Neoplasm Locally Advanced Skin Squamous Cell Carcinoma Metastatic Malignant Neoplasm Metastatic Skin Squamous Cell Carcinoma Metastatic Small Intestinal Adenocarcinoma Rare Neoplastic Syndrome Refractory Malignant Neoplasm Stage IV Small Intestinal Adenocarcinoma AJCC v8 Unresectable Malignant Neoplasm||Drug: Atezolizumab Drug: Cobimetinib||Phase 2|
I. To evaluate the efficacy of cobimetinib plus atezolizumab (COTEZO) in cohorts of advanced rare tumors using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
I. To determine progression-free survival (PFS) on COTEZO in cohorts of advanced rare tumors per RECIST v1.1 and immune-related (ir)RECIST.
II. To determine overall survival (OS) on COTEZO in cohorts of advanced rare tumors.
III. To determine disease control rate (DCR) and duration of response (DOR) on COTEZO in cohorts of advanced rare tumors per RECIST v1.1 and irRECIST.
IV. To determine objective response rate (ORR) per immune-related RECIST criteria.
V. To determine safety profile and adverse events encountered by patients with advanced rare tumors treated with COTEZO.
VI. To collect and bank tumor tissue and peripheral blood for future correlative analyses from patients with advanced rare tumors treated with COTEZO.
Participants receive cobimetinib orally (PO) once daily (QD) on days 1-21 and atezolizumab intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants followed up every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-Label, Single-Arm, Multi-Cohort, Proof-of-Principle Study to Investigate the Efficacy of Cobimetinib and Atezolizumab in Advanced Rare Tumors|
|Actual Study Start Date :||April 7, 2017|
|Estimated Primary Completion Date :||July 30, 2020|
|Estimated Study Completion Date :||July 30, 2020|
Experimental: Treatment (cobimetinib, atezolizumab)
Participants receive cobimetinib PO QD on days 1-21 and atezolizumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Overall Response Rate (ORR) [ Time Frame: 8 weeks ]ORR (partial response (PR) or complete response (CR) measured as per RECIST 1.1.
- Progression-Free Survival (PFS) [ Time Frame: 2 weeks after last dose of study drugs ]PFS assessed per RECIST v1.1.
- Progression-Free Survival (PFS) [ Time Frame: 2 weeks after last dose of study drugs ]PFS assessed per irRECIST.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108131
|Contact: Kanwal P. Raghav||713-792-2828||KPRaghav@mdanderson.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Kanwal P. Raghav 713-563-1701 firstname.lastname@example.org|
|Principal Investigator: Kanwal P. Raghav|
|Principal Investigator:||Kanwal P Raghav||M.D. Anderson Cancer Center|