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Cytokine

Pembrolizumab + Interleukin-12 for Cancer

Phase 1
Waitlist Available
Led By Diwakar Davar
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have tumors with an FDA-approved indication for anti-PD-(L)1 therapy and have progressed past anti-PD(L)1 therapy
Age >= 18 years
Must not have
Diagnosis of immunodeficiency or recent systemic steroid therapy
Uncontrolled intercurrent illnesses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (autoimmunity), infusion-related reactions from receiving the drug into a vein, fatigue, changes in blood counts which could increase infection risk or cause bleeding issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has not responded to previous anti-PD-(L)1 therapy.
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I am 18 years old or older.
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I am mostly active and can care for myself.
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My cancer has spread and cannot be removed with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an immune system disorder or have recently been on steroids.
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I do not have any unmanaged ongoing illnesses.
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I have had a condition where my lymphocytes grow abnormally.
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I have a history of autoimmune blood disorders.
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I have a secondary blood cancer.
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I have not received a live vaccine recently.
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I have active brain tumors or cancer that has spread to my brain.
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I am on medication for an autoimmune disease.
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I have recently been on corticosteroid medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
CD8+ T cell infiltration
Incidence of adverse events
Overall response rate
+1 more
Other study objectives
Biomarker analysis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2011
Completed Phase 2
~2200
Pembrolizumab
2017
Completed Phase 3
~2810
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Computed Tomography
2017
Completed Phase 2
~2740

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Monoclonal antibody immunotherapy, such as pembrolizumab, targets specific proteins like PD-1 on cancer cells to block inhibitory signals and enhance the immune system's ability to attack the tumor. Cytokine therapy, such as recombinant interleukin-12, boosts the immune response by stimulating white blood cells and inhibiting blood flow to the tumor. These targeted approaches are crucial for solid tumor patients as they enhance the body's natural defenses against cancer, potentially leading to better outcomes and fewer side effects compared to traditional therapies.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,011,992 Total Patients Enrolled
Diwakar DavarPrincipal InvestigatorUniversity of Pittsburgh Cancer Institute LAO

Media Library

Edodekin alfa (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT03030378 — Phase 1
Cancer Research Study Groups: Treatment (recombinant interleukin-12, pembrolizumab)
Cancer Clinical Trial 2023: Edodekin alfa Highlights & Side Effects. Trial Name: NCT03030378 — Phase 1
Edodekin alfa (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03030378 — Phase 1
~5 spots leftby Dec 2025