RecruitingPhase 2NCT06015724

Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer

A Phase 2 Study Evaluating the Efficacy of Anti-CD38 Antibody in Combination With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer


Sponsor

Georgetown University

Enrollment

54 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test the safety and tolerability of anti-CD38 monoclonal antibody (mAb), daratumumab, in combination with KRAS vaccine (Targovax TG-01/Stimulon QS-21) when given with anti-PD-1 (programmed cell death protein 1) mAb (nivolumab) in patients with advanced non-small cell lung cancer (NSCLC) or pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are: * How well does daratumumab and nivolumab, when given with a vaccine, control or stop these types of cancer? * How well does participants bodies handle these study drugs? * Does this combination of study drugs help participants live longer? Participants will receive daratumumab, nivolumab with KRAS vaccine and have regular tests and procedures to follow how the participants are doing on these study drugs.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of three treatments — an immune-boosting antibody (anti-CD38), a KRAS cancer vaccine, and an immune checkpoint drug (anti-PD-1) — in people with advanced pancreatic cancer or lung cancer that has stopped responding to standard immunotherapy. **You may be eligible if...** - You are 18 or older - You have advanced non-small cell lung cancer that worsened on PD-1/PD-L1 therapy, OR pancreatic cancer that failed one prior treatment - Your tumor has a KRAS mutation - You are well enough to do light activity (ECOG 0–2) - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You are pregnant, breastfeeding, or not using contraception - You recently had surgery, chemo, or radiation (within the required washout period) - You have uncontrolled heart disease, active infection, or HIV/Hepatitis B/C - You have previously received an anti-CD38 drug (like daratumumab) - You have active autoimmune disease requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab

anti-CD38 monoclonal antibody (mAb)

BIOLOGICALKRAS vaccine

Stimulon QS-21 and Targovax TG01

DRUGNivolumab

anti-PD-1 (programmed cell death protein 1) monoclonal antibody (mAb)


Locations(2)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

View Full Details on ClinicalTrials.gov

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NCT06015724


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