Immune Therapy for Germ Cell Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen bySamuel Funt, MD

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?

The purpose of this study is to test the safety and effectiveness of durvalumab with tremelimumab in patients with relapsed or refractory germ cell tumors.

Eligibility Criteria

Adults over 18 with relapsed/refractory germ cell tumors, weighing more than 30 kg, and having a performance status of 0-2. They must have measurable disease or elevated tumor markers and be willing to follow contraception guidelines if applicable. Excluded are those with recent major surgery, certain medical conditions like autoimmune disorders or lung issues, previous immune therapy treatments, uncontrolled illnesses, or infections like HIV.

Inclusion Criteria

I am 18 years old or older.

I weigh more than 30 kilograms.

My cancer has worsened after at least one treatment.

See 7 more

Exclusion Criteria

I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.

I am not pregnant or breastfeeding.

Previous enrolment in the present study

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Treatment Details

Interventions

Durvalumab, Tremelimumab (Checkpoint Inhibitor)

Trial OverviewThe trial is testing the combination of two immune therapies: Durvalumab (MEDI4736) and Tremelimumab for patients whose germ cell tumors have returned or resisted treatment. It aims to determine how safe and effective this combination is in managing these types of tumors.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Duravalumab + TremelimumabExperimental Treatment2 Interventions

Duravalumab/Tremelimumab: Durvalumab and Tremelimumab will be administered by IV every 4 weeks for up to 4 doses/cycles, then Durvalumab by IV every 4 weeks starting at Week 16 for 9 doses (total treatment duration of 12 months). Participants enrolled now will receive tremelimumab \*300mg with durvalumab 1500mg for 1 cycle followed by 12 cycles of durvalumab 1500mg every 4 weeks or until lack of clinical benefit or unacceptable toxicity.