What side effects are associated with this type of intervention?

Treatments for colorectal cancer involving immune checkpoint inhibitors like Nivolumab (PD-1 inhibitor) and Ipilimumab (CTLA-4 inhibitor) are associated with a range of immune-related adverse events. Common side effects include skin reactions, endocrine disorders, gastrointestinal issues, and fatigue. More severe side effects can include pneumonitis, colitis, hepatitis, and endocrinopathies. Adjuvants such as Poly-ICLC, which enhance immune responses, may also increase the risk of these immune-related side effects.

What prior FDA approvals exist?

The FDA has approved several immunotherapy treatments for colorectal cancer, particularly for patients with specific genetic profiles. Nivolumab (a PD-1 inhibitor) and ipilimumab (a CTLA-4 inhibitor) have been approved for use in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) metastatic colorectal cancer. These approvals are based on their ability to enhance the immune system's response against cancer cells. While there is limited evidence for the use of immunotherapy in microsatellite stable (MSS) colorectal cancer, ongoing research, such as the trial involving the pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant, aims to explore new avenues for treating KRAS-mutated colorectal cancer.

What other types of research exist?

Promising novel alternatives for colorectal cancer treatment in 2024 include: 1) Pembrolizumab (PD-1 inhibitor) combined with chemotherapy, which has shown improved progression-free survival and overall survival in metastatic settings. 2) High-dose Vitamin D3 supplementation, which has been associated with improved progression-free survival in advanced colorectal cancer. 3) Immune checkpoint blockade with anti-PD-1 or anti-PD-L1 therapy, potentially combined with other agents like GM-CSF or fecal microbiota transplantation, which have shown efficacy in other cancer types and are under investigation for colorectal cancer.

← Back to Search

Checkpoint Inhibitor

Cancer Vaccine + Nivolumab + Ipilimumab for Pancreatic and Colorectal Cancer

Phase 1

Recruiting

Led By Neeha Zaidi, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special vaccine combined with immune-boosting drugs for patients with advanced pancreatic or colorectal cancer who have had extensive prior treatments. The goal is to train and enhance the immune system to better fight cancer. The vaccine has been used in previous studies to help the immune system recognize cancer cells in pancreatic cancer patients.

Who is the study for?

Adults over 18 with certain types of pancreatic or colorectal cancer that's been surgically removed and who've had previous chemotherapy can join. They must be in good health, have a life expectancy over 6 months, and use birth control. People can't join if they're on high-dose steroids, had recent radiation or chemo, prior immunotherapy, severe allergies to antibodies, active autoimmune diseases, serious infections including HIV/hepatitis B/C, brain metastases or need oxygen therapy.

What is being tested?

This Phase 1 trial tests the safety and immune response to a new KRAS peptide vaccine combined with Nivolumab and Ipilimumab in patients with specific types of pancreatic and colorectal cancers. The study will see how well this combination works after surgery and standard treatments.

What are the potential side effects?

Possible side effects include typical reactions to vaccines like soreness at the injection site as well as more serious conditions such as inflammation from immune responses caused by Nivolumab and Ipilimumab which could affect various organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fold change in interferon-producing mutant-KRAS-specific cytotoxic (CD8) and helper (CD4) T cells at 16 weeks

Number of participants experiencing study drug-related toxicities

Secondary study objectives

Disease Free Survival (DFS)

Objective Response Rate (ORR) per RECIST 1.1

Overall Survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment PhaseExperimental Treatment3 Interventions

KRAS Vaccine Peptide, Nivolumab and Ipilimumab

Group II: Reinduction Treatment PhaseExperimental Treatment3 Interventions

KRAS Vaccine Peptide, Nivolumab and Ipilimumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Ipilimumab

2015

Completed Phase 3

~3420

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include immunotherapy and targeted therapies. Immunotherapy, such as the combination of nivolumab (a PD-1 inhibitor) and ipilimumab (a CTLA-4 inhibitor), works by blocking proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. Targeted therapies, like the Pooled Mutant-KRAS Peptide Vaccine with Poly-ICLC Adjuvant, specifically target cancer cells with KRAS mutations and stimulate an immune response against these mutations. These treatments are crucial for colorectal cancer patients as they offer personalized and potentially more effective options, especially for those with specific genetic mutations or who are resistant to conventional therapies.