RecruitingColorectal CancerPancreatic Cancer
KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
Phase 1b study evaluating the efficacy and immune response to a synthetic long peptide mutant KRAS vaccine (SPL mKRASvax) combined with Balstilimab and Botensilimab for unresectable or metastatic mismatch repair-proficient (MMR-p) colorectal cancer (mCRC) or unresectable or metastatic MMR-p pancreatic ductal adenocarcinoma (PDAC) patients with measurable disease following first-line chemotherapy.
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
You may qualify if…
- ✓ Age ≥18 years.
- ✓ Have histologically or cytologically - proven cancer of the pancreas or colon.
- ✓ Have tumor lesions amenable to repeated biopsy, and patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
- ✓ Measurable disease as per RECIST 1.1.
- ✓ Have sufficient and accessible tissue for next generation sequencing (NGS) and immune-phenotyping.
- ✓ Have one of the KRAS mutations included in the vaccine at the time of vaccination expressed in tumor.
- ✓ Cohort A: Have received 4-6 months of FOLFIRINOX or gemcitabine+nab-paclitaxel for the 1st line treatment of metastatic unresectable PDAC.
- ✓ Cohort B: Have received 4-6 months of 1st line SOC chemotherapy per NCCN guidelines (FOLFIRINOX, FOLFOX, FOLFIRI +/- targeted therapy with VEGFi or EGFRi) of metastatic CRC.
You may not qualify if…
- ✕ Is a candidate for definitive surgical resection.
- ✕ Known history or evidence of brain metastases and/or leptomeningeal spread.
- ✕ Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
- ✕ Receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days of vaccine treatment.
- ✕ Has active autoimmune disease that has required systemic treatment in the past 5 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
- ✕ Known history or concurrent interstitial lung disease.
- ✕ Has a pulse oximetry \< 95% on room air.
- ✕ Requires the use of home oxygen.
Where it's recruiting
Maryland
Baltimore
Source: ClinicalTrials.gov · NCT06411691 · last updated 2026-07-31