Triple Therapy for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen ByNeil H Segal,, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This study will test whether the combination of cisplatin, nivolumab, and temozolomide is an effective treatment for in people with advanced and/or metastatic colorectal cancer that is mismatch repair-proficient (MMR-proficient). The researchers will also look at how safe the study drug combination is in participants.

Eligibility Criteria

Adults with advanced colorectal cancer that's spread and hasn't responded to at least two standard chemotherapies can join this trial. They need a certain level of blood cells, good organ function, and no major health issues like HIV or active infections. Pregnant or breastfeeding individuals are excluded.

Inclusion Criteria

I am fully active or can carry out light work.

My colorectal cancer cannot be removed by surgery and has spread.

My cancer is not caused by changes in the BRAF or POLE genes.

My kidney function is within the required range.

I am 18 years old or older.

My liver enzymes are within the required range.

My diagnosis is colorectal cancer confirmed by lab tests.

My cancer is not caused by a specific genetic mismatch repair deficiency.

Exclusion Criteria

I am not on high-dose steroids or other drugs that weaken my immune system.

I haven't had cancer treatment in the last 2 weeks and have recovered from side effects.

I have not received treatments targeting immune checkpoints.

I have been diagnosed with HIV.

I am currently being treated for an infection.

Participant Groups

The study is testing a combination of three drugs: Temozolomide (TMZ), Cisplatin, and Nivolumab in people whose colorectal cancer has not been helped by standard treatments. It aims to see if this mix is safe and works better for those with specific genetic features in their tumors.

1Treatment groups

Experimental Treatment

Group I: temozolomide, cisplatin and nivolumabExperimental Treatment3 Interventions

Subjects will receive oral TMZ at 150-200 mg/m2 day 1 to 5 every 4 weeks, cisplatin via IV infusion at 40 mg/m2 every two weeks (Q2W), and nivolumab via IV infusion at 480 mg every four weeks (Q4W).

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: