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OncoMatch/Clinical Trials/NCT06015724

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

Is NCT06015724 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including KRAS vaccine and Daratumumab for pancreatic ductal adenocarcinoma.

Phase 2RecruitingGeorgetown UniversityNCT06015724Data as of May 2026

Treatment: Daratumumab · KRAS vaccine · NivolumabThe 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.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: KRAS mutation in codon 12 (12A, C, D, R, S, V) or 13 (13D)

All patients with mutant KRAS status in either codon 12 (12A, C, D, R, S, V) or 13 (13D) will be included.

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: anti-PD-1/PD-L1 therapy — frontline (NSCLC)

NSCLC, progressing on frontline anti-PD-1/PD-L1 containing therapy

Must have received: any prior treatment — any (PDAC)

PDAC patients who failed one prior treatment

Cannot have received: anti-CD38 therapy (daratumumab)

Daratumumab or other anti-CD38 therapies

Cannot have received: anti-PD-1/PD-L1 therapy

Exception: for NSCLC: anti-PD-1/PD-L1 therapy or second line therapy ≤4 weeks prior to registration

For NSCLC: anti-PD-1/PD-L1 therapy or second line therapy ≤4 weeks prior to registration

Cannot have received: anti-PD-1 therapy

for PDAC: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways

Cannot have received: anti-PD-L1 therapy

for PDAC: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways

Cannot have received: anti-CTLA-4 therapy

for PDAC: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways

Cannot have received: T cell co-stimulation or checkpoint pathway inhibitor

for PDAC: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways

Cannot have received: chemotherapy

Exception: ≤4 weeks prior to registration

Chemotherapy ≤4 weeks prior to registration

Cannot have received: surgery

Exception: ≤3 weeks prior to registration

Surgery ≤3 weeks prior to registration

Cannot have received: focal radiation therapy

Exception: within 14 days prior to first study treatment (except palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma)

Focal radiation therapy within 14 days prior to first study treatment with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma

Cannot have received: complementary medications

Exception: <2 weeks prior to first study treatment

Treatment with complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within <2 weeks prior to first study treatment

Cannot have received: live/attenuated vaccine

Exception: within 30 days of first study treatment

Treatment with any live / attenuated vaccine within 30 days of first study treatment

Lab requirements

Blood counts

hemoglobin ≥9.0 g/dl; absolute neutrophil count (anc) ≥1500/mm3; platelet count ≥100,000/mm3

Kidney function

calculated creatinine clearance (crcl) ≥20 ml/min using the cockcroft-gault formula

Liver function

total bilirubin ≤1.5 x uln; alt and ast ≤3 x uln (≤5 x uln for patients with liver involvement)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Georgetown Lombardi Comprehensive Cancer Center · Washington D.C., District of Columbia
  • John Theurer Cancer Center at Hackensack University Medical Center · Hackensack, New Jersey

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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