Phase 2
N=6
Combination Immunotherapy in Biochemically Recurrent Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03315871 ↗Enrolled (actual)
6
Serious AEs
15.0%
Results posted
Jun 2025
Primary outcome: Primary: Percentage of Participants With a Toxicity — 6; 7; 24 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Antigen direct immunotherapy: PROSTVAC-V (Biological); Antigen direct immunotherapy: PROSTVAC-F (Biological); MSB0011359C (M7824) (Drug); Antigen direct immunotherapy: CV301 (Biological); CT scan of chest (Diagnostic_test); CT scan of abdomen/pelvis (Diagnostic_test); MRI (Diagnostic_test); PSMA (Diagnostic_test); Bone scan (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Toxicity |
6; 7; 24 | — |
| PRIMARY Prostate Specific Antigen (PSA) Response |
0; 0; 0 | — |
| SECONDARY Number of Participants With Related and/or Unrelated Grade 3 and Grade 4 Adverse Events. |
1; 1; 0; 0; 1; 0 | — |
| SECONDARY Number of Evaluable Participants With Biochemical Recurrence (BCR) With a 20% Change in PSA Doubling Time |
2; 23; 1; 11 | — |
Summary
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 (rilimogene galvacirepvec/rilimogene glafolivec vaccinia), CV301, and MSB0011359C (M7824) can induce an anti-tumor impact 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.
Eligibility Criteria
- For Safety Lead-in
- INCLUSION CRITERIA:
- 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.
- Recovery to baseline from acute toxicity related to prior therapy, including surgery and radiation. (28 days removed from last systemic therapy, 14 days removed from last radiation therapy).
- Hepatic function eligibility parameters (within 16 days before starting therapy):
--Bilirubin less than or equal to upper limit of normal (ULN) (OR in participants with Gilbert's syndrome, a total bilirubin less than or equal to 3.0), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 1.5 times upper limit of normal.
- Adequate renal function defined by an estimated creatinine clearance > 50 mL/min according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24-hour urine collection.
- No other active malignancies within the past 36 months (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder) or life-threatening illnesses.
- Willing to travel to the NIH for follow-up visits.
- 18 years of age or older.
- Able to understand and sign informed consent.
- The effects Prostvac (rilimogene galvacirepvec/rilimogene glafolivec) and CV301 on the developing human fetus are unknown. For this reason, men must agree to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) prior to study entry, for the duration of study therapy and at least four months after the last treatment administration. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
- Additional Inclusion Criteria Specific to Safety Lead-In Cohort
- Castrate testosterone level ( 1 week (2 separate increasing values over a minimum of 2ng/ml (Prostate Cancer Working Group 2 (PCWG2) PSA eligibility criteria). If participants had been on flutamide, PSA progression is documented 4 weeks or more after withdrawal. For participants on bicalutamide or nilutamide disease progression is documented 6 or more weeks after withdrawal.
--Participants must agree to continuation of androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone agonist/antagonist or bilateral orchiectomy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky >80%).
- Hematological eligibility parameters (within 16 days before starting therapy):
- Granulocyte count greater than or equal to 1000/mm^3
- Platelet count greater than or equal to 100 000/mm^3
- Hemoglobin (Hgb) greater than or equal to 9 g/dL
- Prothrombin time (PT) less than or equal to 1.5 x ULN
- Activated partial thromboplastin time (aPTT) less than or equal to 1.5 x ULN
Additional Inclusion Criteria Specific to Biochemical Recurrence Cohort
- Biochemical progression defined as follows:
- For participants following definitive radiation therapy: a rise in PSA of greater than or equal to 2 ng/mL above the nadir (per Radiation Therapy Oncology Group (RTOG) -American Society for Therapeutic Radiation Oncology (ASTRO) consensus criteria)
- For participants following radical prostatectomy: rising PSA after surgical procedure (participants must have a PSA greater than or equal to 0.8 ng/mL)
- Participants must have a rising PSA as confirmed by 3 values a minimum of 1 week apart over at least a 1 month period of time.
- Participants must have a PSA doubling time of 5-15 months.
- ECOG performance status of 0-1 (Karnofsky greater than or equal to 80%).
- Negative computed tomography (CT) scan/magnetic resonance imaging (MRI) an
Data sourced from ClinicalTrials.gov (NCT03315871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.