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.
Treatment: Daratumumab · KRAS vaccine · Nivolumab — 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.
Check if I qualifyExtracted 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
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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