Actively Recruiting
Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer
Led by Georgetown University · Updated on 2025-07-28
54
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients with advanced NSCLC progressing on frontline anti-PD-1/PD-L1 therapy (excluding rapid tumor progression) or PDAC patients who failed one prior treatment
- Measurable disease by irRECIST criteria (excluding lesions only in previously irradiated areas or measurable by physical exam only)
- Presence of mutant KRAS in codon 12 or 13
- Prior treatment: for NSCLC, anti-PD-1/PD-L1 therapy with a 4-week washout; for PDAC, failure of one prior treatment
- Written informed consent provided
- Willingness to return for follow-up during active monitoring phase
- Willingness to provide mandatory blood and tissue specimens for research
- ECOG Performance Status 0, 1, or 2
- Laboratory values within 14 days prior to registration meeting specified thresholds for hemoglobin, ANC, platelets, bilirubin, liver enzymes, coagulation, and creatinine clearance
- Negative pregnancy test within 7 days prior to registration for persons of childbearing potential
You will not qualify if you...
- Pregnant, nursing, or unwilling to use adequate contraception if of childbearing potential
- Prior therapies including daratumumab or other anti-CD38 therapies, surgery within 3 weeks, chemotherapy within 4 weeks, recent anti-PD-1/PD-L1 or second-line therapy for NSCLC within 4 weeks, or prior checkpoint inhibitors for PDAC
- Focal radiation therapy within 14 days prior to first treatment (except specific palliative cases) without recovery from toxicities
- Use of complementary medications to treat the disease within 2 weeks prior to first treatment (except supportive care)
- Live or attenuated vaccine within 30 days prior to first treatment
- Severe concurrent illness or conditions interfering with safety assessment
- Uncontrolled infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting compliance
- Receiving other investigational agents for the primary cancer
- Other active malignancies within 5 years except certain cured non-invasive cancers
- History of recent myocardial infarction or severe heart conditions
- Known primary CNS malignancy or symptomatic CNS metastases with specific exceptions for asymptomatic disease
- History of severe allergic reactions to antibodies or vaccines
- Planned yellow fever or live vaccines during study
- History or current bleeding disorders with significant hemorrhage
- Use of supraphysiologic steroids within 6 weeks prior to study drug initiation with specific exceptions
- Significant liver disease including active hepatitis or cirrhosis
- History or risk of autoimmune diseases with specific controlled exceptions
- History of idiopathic pulmonary fibrosis, pneumonitis, or active pneumonitis on screening CT except radiation fibrosis
- Infection greater than grade 2 within 4 weeks prior to registration
- Seropositive for HIV, hepatitis B or C under certain conditions
- COPD with FEV1 less than 50% predicted
- Moderate or severe persistent asthma in past 2 years or uncontrolled asthma
- Prisoners or compulsory detained individuals
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
Research Team
S
Shannon Raue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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