Combination Immunotherapy for Prostate Cancer

Overseen By Willie C Jackson

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must be taking: Androgen deprivation therapy

Must not be taking: 5-alpha reductase inhibitors

Disqualifiers: HIV, Autoimmune diseases, Organ transplant, 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: 6

Duration: 7 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Some people with prostate cancer have a rise in prostate-specific antigen (PSA). This can happen even after treatments like radiation and surgery. Androgen deprivation therapy (ADT) drugs and close monitoring are one standard way to treat this group of people. Another way is to monitor people and their PSA values over time. Researchers want to see if a combination of new drugs can help these people. Objective: To see if the combination treatment of PROSTVAC, CV301, and MSB0011359C (M7824) can induce an anti-tumor attack in people with biochemically recurrent prostate cancer. Eligibility: People ages 18 and older with certain kinds of prostate cancer Design: Participants will be screened with * Medical history * Physical exam * Blood and urine tests * A scan of the neck, chest, abdomen, and pelvis * A bone scan A sample of tissue that was already taken will be tested. This will confirm the diagnosis, stage, and disease status. Some participants will have close monitoring with four monthly PSA checks. All participants will get two study drugs as shots under the skin. They will get the third drug in a vein. They will get the drugs over at least 7 months. Their vital signs will be checked before they get the drugs and for up to 1 hour after. Participants will have frequent study visits. They will have physical exams, urine and blood tests, and scans. Participants will return to the clinic about 4 weeks after they stop taking the study drugs. They will have a medical history, physical exam, and blood tests. They may also have long-term follow-up visits.

Research Team

Ravi A Madan, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Men aged 18+ with specific prostate cancer types, who've had a rise in PSA after treatments like surgery or radiation. They must agree to use effective contraception and have no other active cancers or life-threatening illnesses. Participants should not have received certain therapies recently and must be willing to travel for follow-up visits.

Inclusion Criteria

Negative CT scan/MRI and bone scan for metastatic prostate cancer.

I am fully active or can carry out light work.

Histopathological documentation of prostate cancer confirmed in either the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, or Walter Reed National Military Medical Center prior to enrollment. If no pathologic specimen is available, participants may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.

Exclusion Criteria

- Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with participant's ability to carry out the treatment program.

I am not taking medications like finasteride or saw palmetto that affect PSA levels.

You are allergic to eggs or certain antibiotics like gentamicin or tobramycin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surveillance

Participants undergo a surveillance period with up to 4 consecutive monthly PSA values captured

4 months

4 visits (in-person)

Treatment

Participants receive Prostvac and CV301 vaccines concurrently for 4 months, followed by MSB0011359C for 3 months

7 months

Frequent visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Long-term follow-up

Participants may have long-term follow-up visits to monitor PSA and immune responses

Treatment Details

Interventions

• CV301
• MSB0011359C (M7824)
• PROSTVAC-F
• PROSTVAC-V

Trial Overview The trial tests if the combination of PROSTVAC, CV301, and MSB0011359C (M7824) can trigger an anti-tumor response in patients with biochemically recurrent prostate cancer. Patients will receive these drugs over at least 7 months and undergo regular monitoring including blood tests, scans, and physical exams.

Participant Groups

Group I: 3/combination vaccine therapy +/- surveillance Experimental Treatment 3 Interventions

Surveillance as needed followed by Prostvac + CV301

Group II: 2/combination therapy + surveillance (closed) Experimental Treatment 4 Interventions

Surveillance followed by Prostvac + CV301 then Prostvac + CV301 + MSB0011359C

Group III: 1/combination therapy (closed December 2018) Experimental Treatment 4 Interventions

Prostvac + CV301+ MSB0011359C

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+