Anti-CD38 Antibody, KRAS Vaccine, and Anti-PD-1 Antibody for Pancreatic and Lung Cancer
This study is testing a combination of treatments for advanced non-small cell lung cancer (NSCLC) that has progressed after initial therapy, or pancreatic ductal adenocarcinoma (PDAC) after one prior treatment. The treatments include Daratumumab (an anti-CD38 antibody), a KRAS vaccine (Stimulon QS-21 and Targovax TG01), and Nivolumab (an anti-PD-1 antibody). Researchers want to see how well this combination controls or stops cancer growth, how your body handles these drugs, and if it helps people live longer. You might be able to join if you are at least 18 years old and have measurable disease. The study aims to enroll 19 participants and will measure how many people respond to the treatment.
- Study design
- This study is an interventional trial with a planned enrollment of 19 participants. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, Objective Response Rate, will be measured every 8 weeks for approximately 2 years.
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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
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentGeorgetown UniversityInvestigator-initiated
~19 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:DaratumumabKRAS vaccineNivolumab
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) (Efficacy)
Measured over every 8 weeks, approximately 2 years
Conditions
Where it's being run
1 sites across 1 statesDistrict of Columbia1
Study leadership
- Samir Khleif, MD · PRINCIPAL_INVESTIGATOR · Georgetown University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
For NSCLC: Anti-PD1/PD-L1 containing therapy; a wash-out period of 4 weeks from the last administration of therapy would be allowed.
For PDAC: Patients who failed one prior treatment. 6. Provide written informed consent. 7. Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study). 8. Willingness to provide blood specimens for correlative research. 9. Willingness to provide tissue specimens for correlative research (when available/feasible). 10. ECOG Performance Status (PS) 0, 1 or 2. 11. The following laboratory values obtained ≤14 days prior to registration:
Hemoglobin ≥9.0 g/dL
Absolute neutrophil count (ANC) ≥1500/mm3
Platelet count ≥100,000/mm3
Total bilirubin ≤1.5 x ULN (upper limit of normal)
ALT and AST ≤3 x ULN (≤5 x ULN for patients with liver involvement)
PT (prothrombin time)/INR/aPTT (activated partial thromboplastin time) ≤1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy
Calculated creatinine clearance (CrCl) ≥20 mL/min using the Cockcroft-Gault formula 12. Negative pregnancy test done ≤7 days prior to registration, for persons of childbearing potential only.
Exclusion
Pregnant persons
Nursing persons
Persons of childbearing potential who are unwilling to employ adequate contraception 2. Any of the following prior therapies:
Daratumumab or other anti-CD38 therapies
Surgery ≤3 weeks prior to C1D1
Chemotherapy ≤4 weeks prior to C1D1 or 2 half-lives, whichever is shorter
For NSCLC: anti-PD-1/PD-L1 therapy or second line therapy ≤4 weeks prior to registration; 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.
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. Participants must have recovered (ie, Grade ≤1 or at baseline) from radiation-related toxicities 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. Such medications are permitted if they are used as supportive care.
Treatment with any live / attenuated vaccine within 30 days of first study treatment. 3. Co-morbid systemic illnesses or other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. 4. Uncontrolled intercurrent illness including, but not limited to:
Unstable angina pectoris
Cardiac arrhythmia
Or psychiatric illness/social situations that would limit compliance with study requirements. 5. Receiving any other investigational agent, which would be considered as a treatment for the primary neoplasm. 6. Other active malignancy ≤5 years prior to registration. EXCEPTIONS: Squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesions that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years. 7. History of myocardial infarction ≤6 months, or CHF (class II and above that are not properly controlled on maintenance therapy or that have been hospitalized in the last 4 weeks for heart failure) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias. 8. Patients with known primary CNS malignancy or symptomatic CNS metastases are excluded, with the following exceptions:
Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:
Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:
Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
No stereotactic radiation or whole-brain radiation ≤28 days prior to registration
Screening CNS radiographic study ≥4 weeks from completion of radiotherapy and ≥ 2 weeks from discontinuation of corticosteroids 9. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins or vaccines. 10. Patients with a plan to receive yellow fever or other live (attenuated) vaccines during the course of study. 11. Patients who have a history or current evidence of bleeding disorder, i.e., any hemorrhage/bleeding event of CTCAE Grade ≥2, ≤28 days prior to registration. 12. Patients on supraphysiologic doses of steroids taken within 6 weeks of study drug initiation. Exceptions:
Seropositive for HIV.
Seropositive for hepatitis B (defined by a positive test for HBsAg). Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for anti-HBc and/or anti-HBs) must be screened using RT-PCR measurement of HBV DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
Seropositive for hepatitis C (except in the setting of a SVR, defined as aviremia at least 12 weeks after completion of antiviral therapy).
Note: HIV and HCV testing at screening is at the investigator's discretion. Serological testing if already performed within 3 months of starting the study drugs may be used. All subjects will be tested locally for HBsAg, Anti-HBs, and Anti-HBc at Screening.
What this trial measures
- Objective Response Rate (ORR) (Efficacy)every 8 weeks, approximately 2 years
Evaluation of response by ORR by irRECIST criteria. Response classification will follow the irRECIST criteria and will be defined as PR or CR. Patients who are lost to follow-up without a valid response assessment will be classified as NR (non-responder, progression). The ORR will be computed for all patients with at least one cycle of the study drug.