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Checkpoint Inhibitor
Cobimetinib + Atezolizumab for Rare Cancers
Phase 2
Waitlist Available
Led By Kanwal P Raghav
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Must have histologically or cytologically documented rare tumor as defined per protocol that is metastatic or locally advanced and unresectable. Patients with locally advanced cutaneous squamous cell carcinoma that are technically resectable but in whom surgery is expected to lead to substantial function impairment or disfigurement are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to treat rare tumors that have progressed or are resistant to treatment. Cobimetinib blocks enzymes needed for cell growth, while atezolizumab helps the immune system attack cancer cells. The hope is that the combination of these drugs will be more effective in treating advanced or refractory rare tumors.
Who is the study for?
This trial is for adults with advanced or treatment-resistant rare tumors, including various carcinomas and squamous cell cancers. Participants must have tried standard therapies without success, be able to swallow pills, and provide tumor tissue samples. They should not be pregnant or breastfeeding and must agree to use effective contraception.Check my eligibility
What is being tested?
The study tests the combination of cobimetinib (an enzyme inhibitor) and atezolizumab (a monoclonal antibody immunotherapy) in patients with rare tumors that are either spreading or not responding to treatment. The goal is to see if this drug combo can better control cancer growth compared to current methods.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, fatigue, digestive issues like nausea or diarrhea, liver function changes, skin rash, hormonal imbalances such as thyroid disorders, and an increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My rare cancer is advanced, cannot be surgically removed, and affects my appearance or function.
Select...
I have a type of skin cancer that could be removed but surgery might severely affect my appearance or how my body works.
Select...
My small bowel cancer didn't respond to or I couldn't tolerate a chemotherapy that includes fluorouracil.
Select...
I finished my last cancer treatment over 2 weeks ago and feel mostly recovered.
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My appendiceal cancer cannot be cured with surgery.
Select...
I can swallow pills.
Select...
My condition hasn't improved with standard treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Progression-Free Survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cobimetinib, atezolizumab)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Cobimetinib
2017
Completed Phase 3
~2660
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,753 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,618 Total Patients Enrolled
Kanwal P RaghavPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have skin squamous cell carcinoma.I can take care of myself but might not be able to do heavy physical work.My kidney function test shows a creatinine clearance above 30 ml/min.I do not have any severe illnesses like uncontrolled diabetes, heart problems, or recent heart attacks.I am not pregnant or cannot become pregnant.My rare cancer is advanced, cannot be surgically removed, and affects my appearance or function.I have a type of skin cancer that could be removed but surgery might severely affect my appearance or how my body works.I have not taken any cancer immunotherapy or specific inhibitors for my condition.My small bowel cancer didn't respond to or I couldn't tolerate a chemotherapy that includes fluorouracil.I finished my last cancer treatment over 2 weeks ago and feel mostly recovered.My appendiceal cancer cannot be cured with surgery.I will use effective birth control during and 6 months after treatment as advised.I have no active cancer except for CRC or treated minor cancers.I have HIV or active hepatitis, or had hepatitis B but it's resolved, or had hepatitis C but no current infection.I can provide a high-quality tumor sample or am willing to undergo a biopsy.I do not have a blockage in my small intestine caused by cancer.I do not have a blockage in my bowel caused by cancer.I have a history of serious eye conditions that could affect my retina.I haven't taken any immune-boosting drugs in the last 6 weeks or before their effects wore off.You have or are at risk of developing an autoimmune disease, such as lupus, rheumatoid arthritis, or multiple sclerosis. However, if you have controlled type 1 diabetes or hypothyroidism, you may be eligible. If you have eczema, psoriasis, lichen simplex chronicus or vitiligo with only skin symptoms, you may be eligible if the condition is well-controlled and covers less than 10% of your body surface area.I can swallow pills.My condition hasn't improved with standard treatments.You have had a bone marrow or solid organ transplant in the past.My brain metastases are stable for 30 days, treated, and I haven't taken steroids for 7 days.I have not had severe infections or tuberculosis in the last 4 weeks.I have a history of lung conditions but not active lung inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cobimetinib, atezolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What safety protocols are in place for the cobimetinib and atezolizumab treatment regimen?
"Power evaluated Treatment (cobimetinib, atezolizumab) to be a 2 on the safety scale due to it being in Phase 2. This means there is some evidence of protection but no data suggesting efficacy at this point."
Answered by AI
What therapeutic purpose does the combination of cobimetinib and atezolizumab serve?
"For small cell lung cancer (SCLC), cobimetinib and atezolizumab are popular treatment options. Additionally, this combination of drugs can be beneficial for managing metastatic melanoma, unresectable melanoma, and various types of malignant neoplasms."
Answered by AI
How many patients are partaking in the experiment?
"Sign-ups for this medical trial have closed. Initially posted on April 7, 2017, the study was last updated September 22th 2022. Those seeking alternate clinical trials may find there are 5374 separate studies recruiting patients with rare neoplastic syndrome and 374 studies evaluating treatment (cobimetinib, atezolizumab) that are still open to new participants."
Answered by AI
Is this an unprecedented clinical trial?
"At the current moment, 374 active clinical trials for cobimetinib and atezolizumab are scattered across 1650 cities of 74 different nations. Hoffmann-La Roche first conducted this study in 2008 with 720 subjects, which progressed to Phase 2 drug approval. Since then, 101 investigations have been successfully completed."
Answered by AI
Are there still spots available for participants in this research endeavor?
"As per clinicaltrials.gov, this medical trial is not presently enlisting patients. Inception of the study was on April 7th 2017 and it underwent its last alteration on September 22nd 2022. At present, 5748 other trials are recruiting participants while this one remains inactive."
Answered by AI
Who else is applying?
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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