Is NCT06411691 recruiting in Baltimore, MD?

Yes, NCT06411691 is currently recruiting participants at its Baltimore, MD location. This colorectal cancer clinical trial is actively enrolling qualified participants.

How do I join the colorectal cancer clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Colorectal Cancer Clinical Trial in Baltimore, MD

About This Colorectal Cancer Study in Baltimore

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

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT06411691) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Colorectal Cancer Treatment Options in Baltimore, MD

If you're searching for colorectal cancer treatment options in Baltimore, MD, this clinical trial (NCT06411691) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced colorectal cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all colorectal cancer clinical trials near you to find additional studies recruiting in your area.

Colorectal Cancer Clinical Trial in Baltimore, MD

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