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KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer

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Johns Hopkins Medicine

Status and phase

Begins enrollment this month
Phase 2

Conditions

Pancreatic Cancer
Colorectal Cancer

Treatments

Drug: KRAS Vaccine with Poly-ICLC adjuvant
Drug: Botensilimab
Drug: Balstilimab

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06411691
IRB00427416 (Other Identifier)
J2456

Details and patient eligibility

About

Phase 2 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 FOLFIRINOX/FOLFOXIRI (FFX).

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.
  • Have received 4-6 months of FOLFIRINOX for the treatment of metastatic or unresectable PDAC or CRC.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0.
  • Life expectancy of greater than 3 months.
  • Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
  • Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
  • Men must use acceptable form of birth control while on study.
  • Ability to understand and willingness to sign a written informed consent document.

Exclusion criteria

  • 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.
  • Infection with HIV or hepatitis B or C.
  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Has been diagnosed with another cancer or myeloproliferative disorder within the past 5 year.
  • Has had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement.
  • Has received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment.
  • If at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or other substance abuse (including alcohol) that could potentially interfere with adherence to study procedures or requirements.
  • Any other sound medical, psychiatric, and/or social reason as determined by the Investigator.
  • Unwilling or unable to follow the study schedule for any reason.
  • Are pregnant or breastfeeding.
  • Any radiological or clinical pleural effusions or ascites.
  • History of malignant small bowel obstruction.
  • On parenteral nutrition.
  • Known or suspected hypersensitivity to Hiltonol.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

SLP mKRASvax (Up to 1.8mg peptide + 0.5 mg Poly-ICLC (Hiltonol), Botensilimab and Balstilimab
Experimental group
Treatment:
Drug: Balstilimab
Drug: Botensilimab
Drug: KRAS Vaccine with Poly-ICLC adjuvant

Trial contacts and locations

1

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Central trial contact

Colleen Apostol, RN; Joann Santmyer, RN

Data sourced from clinicaltrials.gov

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