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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of two drugs, pembrolizumab and recombinant interleukin-12, to treat patients with solid tumors.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD)

Recommended phase 2 dose

Secondary outcome measures

CD8+ T cell infiltration

Incidence of adverse events

Overall response rate

+1 more

Other outcome measures

Biomarker analysis

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

Pembrolizumab

2017

Completed Phase 2

~2010

Positron Emission Tomography

2008

Completed Phase 2

~2240

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Biopsy

2014

Completed Phase 4

~850

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,117 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

Solid Tumors Research Study Groups: Treatment (recombinant interleukin-12, pembrolizumab)

Solid Tumors 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the clinical trial enrolling?

"Affirmative. Clinicaltrials.gov confirms that this medical experiment, first listed on August 11th 2017, is still recruiting participants. A total of 36 individuals must be recruited from 8 separate clinical sites."

Answered by AI

Is enrollment for this research study still available?

"As evidenced on clinicaltrials.gov, this medical trial has opened its doors to participants - the original posting was dated August 11th 2017 and it underwent a recent update on December 1st 2022."

Answered by AI

What are the expected results of this research?

"The primary purpose of this extended, 5-year trial is to establish the Maximum Tolerated Dose (MTD). Secondary objectives measure overall response rate using Response Evaluation Criteria in Solid Tumors version 1.1., CD8+ T cell infiltration via immunohistochemistry as compared to pre-treatment biopsy specimens, and incidence of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) grade, category, relatedness and dose level."

Answered by AI

How is Pembrolizumab frequently deployed in medical practice?

"Pembrolizumab has been approved to treat advanced malignancies, unoperable melanomas, and microsatellite instability high cancers."

Answered by AI

Has there been any previous research investigating the efficacy of Pembrolizumab?

"At present, 992 studies related to Pembrolizumab are underway, 122 of which have moved into Phase 3. Houston is the epicentre for these trials, yet 35808 sites in total are conducting research on this medication."

Answered by AI

Has the FDA endorsed Pembrolizumab for medicinal use?

"There is limited clinical evidence attesting to pembrolizumab's safety and effectiveness, so it received a rating of 1."

Answered by AI

To what extent has the trial been distributed throughout localities?

"This medical trial is actively seeking patients and has 8 recruiting sites, including Brigham and Women's Hospital in Boston, University of Pittsburgh Cancer Institute (UPCI) in Pittsburgh, and University of Texas Health Science Center at San Antonio in San Antonio. An additional 5 locations are also offering this study opportunity."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab and Recombinant Interleukin-12 in Treating Patients With Solid Tumors

2018. "Pembrolizumab and Recombinant Interleukin-12 in Treating Patients With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03030378.

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