Pembrolizumab + Interleukin-12 for Cancer

Recruiting in Palo Alto (17 mi)

+27 other locations

Dr. Diwakar Davar, MD - Pittsburgh, PA ...

Overseen byDiwakar Davar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two treatments for patients with solid tumors. One treatment helps the immune system attack cancer, and the other cuts off the tumor's blood supply and boosts the immune response. The goal is to find the best dose and see if this combination works effectively. Combining targeted and immunotherapy is a rapidly growing practice in solid tumors and provides a glimpse of hope in situations that previously lacked any treatment option.

Eligibility Criteria

This trial is for adults with solid tumors that have worsened after anti-PD-(L)1 therapy. They must be in good physical condition, not pregnant or breastfeeding, and willing to use birth control. People can't join if they've had recent cancer treatments, other active cancers, immune system problems, untreated brain metastases, severe allergies to study drugs, or are on steroids.

Inclusion Criteria

My liver and kidney tests are normal.

My cancer has not responded to previous anti-PD-(L)1 therapy.

I am 18 years old or older.

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Exclusion Criteria

I have an immune system disorder or have recently been on steroids.

Known allergic reactions to study compounds

I do not have any unmanaged ongoing illnesses.

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Treatment Details

Interventions

Edodekin alfa (Cytokine)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe trial tests pembrolizumab (an antibody that helps the immune system fight cancer) combined with recombinant interleukin-12 (which may block tumor blood flow and activate white cells against the tumor). It aims to find a safe dose and see if this combo is more effective than pembrolizumab alone.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (recombinant interleukin-12, pembrolizumab)Experimental Treatment7 Interventions

Patients receive recombinant interleukin-12 SC on days 2, 5, 9, and 12 and pembrolizumab IV over 30 minutes on day 8 of cycle 1 and day 1 of subsequent cycles. Treatment continues for 28 days for cycle 1 and repeats every 21 days for subsequent cycles for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patient then receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 additional cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, PET, and MRI, as well as collection of blood during screening, on study, and during follow-up. Patients also undergo a tumor biopsy during screening and on study.