KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer
Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Adenocarcinoma
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a KRAS-targeted vaccine with balstilimab and botensilimab to see how well they work and how the body's immune system responds. It is for adults with colon or rectal cancer or pancreatic ductal cancer that has spread or cannot be removed by surgery, after chemotherapy. The cancer must be MMR-p, meaning it has a working system for fixing certain DNA errors.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, with pancreatic or colon cancer confirmed by a tissue or cell test.
- Have cancer that can be measured and a KRAS gene change targeted by the vaccine.
- Have enough tumor tissue for testing and agree to tumor samples before and during treatment, if safe.
- For group A: have had 4–6 months of first chemotherapy for pancreatic cancer with FOLFIRINOX or gemcitabine plus nab-paclitaxel.
- For group B: have had 4–6 months of standard first chemotherapy for colon or rectal cancer. For group C: have had no more than 3 rounds of different chemotherapy treatments, including prior KRAS-blocking treatment.
- Be fully active, have an expected lifespan over 3 months, and have blood tests showing good enough organ and bone marrow function.
- If able to become pregnant, have a negative pregnancy test and follow study birth control rules. Men must also use birth control.
- Be able to understand the study and willing to sign a consent form.
Who can't join
- Can have surgery to remove the cancer, or have cancer that has spread to the brain or its lining.
- Have had immune-based cancer treatment, or recently used medicines that weaken the immune system. Certain diseases where the immune system attacks the body also rule you out.
- Have lung tissue disease, blood oxygen below 95% without extra oxygen, or need oxygen at home.
- Have HIV, hepatitis B or C, an uncontrolled illness, or another cancer diagnosed in the past 5 years, with some exceptions.
- Had surgery within 28 days, with some exceptions, or a live vaccine to prevent infection within 28 days of study treatment.
- Are pregnant or breastfeeding, or have a known or suspected allergy to Hiltonol.
- Have fluid around the lungs or in the belly, a past small bowel blockage caused by cancer, or receive nutrition through a vein.
- Cannot follow study requirements because of substance use, medical, mental health, or social concerns, or are unwilling to follow the study schedule.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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. * 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. * Cohort C: Have received no more than 3 lines of systemic chemotherapy, including prior KRAS inhibitor. * 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 in the past 5 years except for superficial bladder cancer, non-melanoma skin cancers, DCIS, a low-grade prostate cancer, or a cancer not expected to impact life expectancy and not requiring therapy. * 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.
Study sites (1)
MD
- Sidney Kimmel Comprehensive Cancer Center · Baltimore, MD 21231Colleen Apostol, RN · Study contact · 410-614-3644 · GIClinicalTrials@jhmi.eduMore trials in Baltimore