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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT06015724
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    anti-CD38 monoclonal antibody (mAb)
  • KRAS vaccine — BIOLOGICAL
    Stimulon QS-21 and Targovax TG01
  • Nivolumab — DRUG
    anti-PD-1 (programmed cell death protein 1) monoclonal antibody (mAb)

Study Details

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.

Key Dates

Start date
Jan 31, 2024
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pancreatic Ductal Adenocarcinoma
  • Experimental: Refractory Non-Small Cell Lung Cancer

Primary Outcome Measure

Objective Response Rate (ORR) (Efficacy) [ Time Frame: every 8 weeks, approximately 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Georgetown Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007
Shannon Raue
[email protected]
202-784-5097
Benjamin Weinberg, MD (SUB_INVESTIGATOR)
Joshua Reuss, MD (SUB_INVESTIGATOR)
Samir N. Khleif, MD (PRINCIPAL_INVESTIGATOR)
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777
Martin Gutierrez, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Georgetown Lombardi Comprehensive Cancer Center· Washington D.C., DCJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJ

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