30 Participants Needed

Cancer Vaccine + Nivolumab + Ipilimumab for Pancreatic and Colorectal Cancer

TB
JS
CA
CA
Overseen ByColleen Apostol, RN
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before starting, such as systemic steroids, chemotherapy, and investigational drugs. If you're on these, you may need to stop them 2 to 4 weeks before the trial begins.

What data supports the effectiveness of the treatment involving Cancer Vaccine, Nivolumab, and Ipilimumab for pancreatic and colorectal cancer?

Research shows that a mutant ras peptide vaccine can induce immune responses in pancreatic cancer patients, leading to prolonged survival for those who respond. Additionally, combining cancer vaccines with immune checkpoint inhibitors like Nivolumab may enhance the immune system's ability to fight tumors, potentially improving outcomes in patients with pancreatic cancer.12345

Is the combination of cancer vaccine, Nivolumab, and Ipilimumab safe for humans?

The combination of cancer vaccines with Nivolumab has been generally well-tolerated in clinical trials for pancreatic cancer, with no severe adverse events reported. This suggests that the treatment is generally safe in humans, although specific data on the combination with Ipilimumab is not provided.36789

How is the treatment with Cancer Vaccine, Nivolumab, and Ipilimumab different from other treatments for pancreatic and colorectal cancer?

This treatment is unique because it combines a cancer vaccine targeting specific cancer mutations with two immune checkpoint inhibitors, Nivolumab and Ipilimumab, which help the immune system recognize and attack cancer cells. This approach aims to enhance the body's immune response against cancer, potentially offering a new option for patients with limited treatment choices.1341011

What is the purpose of this trial?

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.

Research Team

NA

Nilofer Azad, MD

Principal Investigator

Johns Hopkins Medical Institution

Eligibility Criteria

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.

Inclusion Criteria

I am a man and will use birth control during the study.
I am fully active or restricted in physically strenuous activity but can do light work.
My cancer has returned in one specific area, as shown on scans.
See 11 more

Exclusion Criteria

I haven't had any radiation treatment or gamma knife surgery in the last 2 weeks.
Within 4 weeks prior to first dose of study drug: Any investigational device
I haven't taken high-dose steroids in the last 2 weeks.
See 27 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the KRAS Vaccine Peptide, Nivolumab, and Ipilimumab

16 weeks
Regular visits for treatment administration and monitoring

Reinduction Treatment

Participants may receive additional doses of KRAS Vaccine Peptide, Nivolumab, and Ipilimumab

Variable, based on response

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years
Periodic visits for assessment

Treatment Details

Interventions

  • Ipilimumab
  • KRAS peptide vaccine
  • Nivolumab
Trial Overview 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.
Participant Groups
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

Ipilimumab is already approved in United States, European Union for the following indications:

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Approved in United States as Yervoy for:
  • Advanced melanoma
  • Stage III unresectable melanoma
  • Stage IV metastatic melanoma
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Approved in European Union as Yervoy for:
  • Advanced melanoma
  • Stage III unresectable melanoma
  • Stage IV metastatic melanoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

The WT1/MUC1 dendritic cell vaccination was found to be safe and well-tolerated in 10 patients with surgically resectable pancreatic ductal adenocarcinoma, with no significant toxicities reported.
Preliminary results showed promising overall survival rates at 3 years (77.8%) and a potential link between the vaccination and increased immune response in tumor tissues, suggesting further investigation is needed to assess its clinical benefits.
Dendritic Cell-based Immunotherapy Pulsed With Wilms Tumor 1 Peptide and Mucin 1 as an Adjuvant Therapy for Pancreatic Ductal Adenocarcinoma After Curative Resection: A Phase I/IIa Clinical Trial.Nagai, K., Adachi, T., Harada, H., et al.[2022]
In a phase I/II trial involving 48 patients with pancreatic adenocarcinoma, a vaccine using synthetic mutant ras peptides successfully induced an immune response in 58% of evaluable patients, demonstrating its potential effectiveness even in advanced disease stages.
Patients who developed an immune response to the vaccine had a significantly longer median survival (148 days) compared to non-responders (61 days), suggesting that the vaccine may provide clinical benefits for patients with pancreatic cancer.
Intradermal ras peptide vaccination with granulocyte-macrophage colony-stimulating factor as adjuvant: Clinical and immunological responses in patients with pancreatic adenocarcinoma.Gjertsen, MK., Buanes, T., Rosseland, AR., et al.[2021]
In a study involving 93 patients with metastatic pancreatic cancer, combining GVAX vaccine and cyclophosphamide with nivolumab (Arm A) did not significantly improve overall survival compared to the same treatment without nivolumab (Arm B), with median survival times of 5.9 and 6.1 months, respectively.
Despite not meeting the primary endpoint, Arm A showed some objective tumor responses and beneficial immunologic changes in long-term survivors, such as increased CD8+ T cells, suggesting potential for immune modulation even if overall survival was similar to standard therapies.
Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-Mesothelin (CRS-207) with or without Nivolumab in Patients with Pancreatic Cancer.Tsujikawa, T., Crocenzi, T., Durham, JN., et al.[2023]

References

Dendritic Cell-based Immunotherapy Pulsed With Wilms Tumor 1 Peptide and Mucin 1 as an Adjuvant Therapy for Pancreatic Ductal Adenocarcinoma After Curative Resection: A Phase I/IIa Clinical Trial. [2022]
Intradermal ras peptide vaccination with granulocyte-macrophage colony-stimulating factor as adjuvant: Clinical and immunological responses in patients with pancreatic adenocarcinoma. [2021]
Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-Mesothelin (CRS-207) with or without Nivolumab in Patients with Pancreatic Cancer. [2023]
Pilot study of mutant ras peptide-based vaccine as an adjuvant treatment in pancreatic and colorectal cancers. [2020]
A Phase Ib Study of the Combination of Personalized Autologous Dendritic Cell Vaccine, Aspirin, and Standard of Care Adjuvant Chemotherapy Followed by Nivolumab for Resected Pancreatic Adenocarcinoma-A Proof of Antigen Discovery Feasibility in Three Patients. [2023]
Immunological responses to a multi-peptide vaccine targeting cancer-testis antigens and VEGFRs in advanced pancreatic cancer patients. [2021]
A platform trial of neoadjuvant and adjuvant antitumor vaccination alone or in combination with PD-1 antagonist and CD137 agonist antibodies in patients with resectable pancreatic adenocarcinoma. [2023]
Immunogenicity of Del19 EGFR mutations in Chinese patients affected by lung adenocarcinoma. [2020]
Immunoprevention of KRAS-driven lung adenocarcinoma by a multipeptide vaccine. [2019]
Combination treatment of advanced pancreatic cancer using novel vaccine and traditional therapies. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Immunogenicity and antitumor efficacy of a novel human PD-1 B-cell vaccine (PD1-Vaxx) and combination immunotherapy with dual trastuzumab/pertuzumab-like HER-2 B-cell epitope vaccines (B-Vaxx) in a syngeneic mouse model. [2021]
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