Combination Immunotherapy for Pancreatic Cancer

Overseen By Colleen Apostal, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Steroids, Organic nitrates, Immunosuppressants, others

Disqualifiers: Brain metastases, Autoimmune disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

17 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of four treatments on patients with advanced pancreatic cancer who did not respond to previous chemotherapy. The treatments include a drug to improve blood flow, two therapies to help the immune system fight cancer, and a vaccine to boost the immune response against cancer cells.

Research Team

Katherine Bever, MD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medical Institution

Eligibility Criteria

Adults over 18 with metastatic pancreatic cancer that's worsened after chemotherapy can join this trial. They must understand and agree to the study, have at least one measurable tumor, be in good physical condition (ECOG 0 or 1), use birth control, and have proper organ function. Exclusions include allergies to penicillin/sulfa, brain metastases, recent treatments or surgeries, uncontrolled illnesses, certain drug uses, severe hypersensitivities, significant heart disease or infections like HIV.

Inclusion Criteria

My cancer has worsened as shown by imaging tests.

My blood and organ tests meet the study's requirements.

My cancer is a type of pancreatic cancer confirmed by lab tests.

Exclusion Criteria

I use more than 4 grams of acetaminophen daily.

You are currently using extra oxygen at home.

I had surgery within the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tadalafil, pembrolizumab, ipilimumab, and CRS-207

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CRS-207
• Ipilimumab
• Pembrolizumab
• Tadalafil

Trial Overview The trial is testing a combination of drugs: Tadalafil plus immunotherapies Pembrolizumab and Ipilimumab along with CRS-207 vaccine therapy on those with advanced pancreatic cancer who've had prior chemo. It aims to assess safety and how well these work together against the cancer.

Participant Groups

Group I: Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Lustgarten Foundation

Collaborator

Trials

27

Recruited

5,500+