Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03108131
Phase
PHASE2
Status
Completed

Conditions

  • Appendix Adenocarcinoma
  • Locally Advanced Malignant Neoplasm
  • Locally Advanced Skin Squamous Cell Carcinoma
  • Metastatic Malignant Neoplasm
  • Metastatic Skin Squamous Cell Carcinoma
  • Metastatic Small Intestinal Adenocarcinoma
  • Rare Lesion
  • Rare Neoplastic Syndrome
  • Refractory Malignant Neoplasm
  • Skin Squamous Cell Carcinoma
  • Stage IV Small Intestinal Adenocarcinoma AJCC v8
  • Unresectable Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This phase II trial studies how well cobimetinib and atezolizumab work in treating participants with rare tumors that have spread to other places in the body (advanced) or that does not respond to treatment (refractory). Cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cobimetinib and atezolizumab may work better in treating participants with advanced or refractory rare tumors.

Key Dates

Start date
Apr 7, 2017
Status verified
May 2025
Primary completion
Apr 2, 2024
Completion
Apr 2, 2024

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Patient will be on study up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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