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

NCT06015724 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Daratumumab

anti-CD38 monoclonal antibody (mAb)

BIOLOGICAL

KRAS vaccine

Stimulon QS-21 and Targovax TG01

DRUG

Nivolumab

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

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Janssen, LP

    collaborator INDUSTRY

  • Targovax ASA

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Samir Khleif, MD · Georgetown University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06015724 on ClinicalTrials.gov