Description:
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses
of a vaccine-based immunotherapy regimen for patients with prostate cancer.
Title
- Brief Title: A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
- Official Title: A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING DOSES OF A VACCINE-BASED IMMUNOTHERAPY REGIMEN (VBIR) FOR PROSTATE CANCER (PF-06753512)
Clinical Trial IDs
- ORG STUDY ID:
B7791001
- SECONDARY ID:
PRCA VBIR FIP STUDY
- NCT ID:
NCT02616185
Conditions
Interventions
Drug | Synonyms | Arms |
---|
PF-06755992 | AdC68 | Dose Escalation |
PF-06755990 | pDNA | Dose Escalation |
Tremelimumab | PF-06753388 | Dose Escalation |
PF-06801591 | | Dose Escalation |
PF-06753512 | VBIR-1 or PrCa VBIR | Dose Escalation |
Purpose
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses
of a vaccine-based immunotherapy regimen for patients with prostate cancer.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation | Experimental | PF-06753512 | - PF-06755992
- PF-06755990
- Tremelimumab
- PF-06801591
- PF-06753512
|
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological diagnosis of prostate cancer
- Adequate bone marrow, kidney and liver function
- Hormone sensitive relapsing prostate cancer after definitive local therapy
(biochemical relapse) OR
- Failed prior therapy with a novel hormone (e.g. enzalutamide, abiraterone) with
documented progressive disease (post-novel hormone therapy CRPC)
Exclusion Criteria:
- ECOG performance status greater than or equal to 2
- Concurrent immunotherapy for prostate cancer
- History of or active autoimmune disorders (including but not limited to: myasthenia
gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic
lupus erythematosus, scleroderma) and other conditions that disorganize or alter the
immune system.
- History of inflammatory bowel disease.
- Current use of any implanted electronic stimulation device
- For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no
known prior or current evidence of any metastatic involvement of distant organs
- For post-novel hormone patients, no concurrent treatment with a secondary hormone
(e.g. enzalutamide, abiraterone), no metastasis to the liver or brain
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Part A. Incidence and grade of treatment-emergent adverse events including DLTs |
Time Frame: | Baseline for up to 3 years |
Safety Issue: | |
Description: | DLTs in order to determine the maximum tolerated dose and safety beyond DLT assessment period |
Secondary Outcome Measures
Measure: | Immune response to the selected prostate cancer tumor-antigens |
Time Frame: | Baseline up to Cycle 1 Day 85; Day 1, Day 29 and Day 99 of Cycle 2; every 6 months thereafter up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Antibody response specific to the PSMA antigen |
Time Frame: | Baseline up to Cycle 1 Day 85; Day 1 and Day 99 of Cycle 2; every 4 months thereafter for up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Maximum observed plasma concentration of tremelimumab (Cmax) |
Time Frame: | Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Time to maximum concentration of tremelimumab (Tmax) |
Time Frame: | Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Area under the curve from time zero extrapolated to infinity of tremelimumab |
Time Frame: | Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Trough concentrations after multiple doses of tremelimumab (Ctrough) |
Time Frame: | Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Incidence and titers of anti-drug antibodies against tremelimumab |
Time Frame: | Day 1, Day 29, and Day 85 of Cycle 1 (each Cycle is 16 weeks); Day 29 of Cycle 2; every 4 months thereafter for up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Incidence and titers of neutralizing antibodies against PF-06801591 |
Time Frame: | Day 1, Day 29 and Day 85 of Cycle 1 (each Cycle is 16 weeks); Day 29 of Cycle 2; every 4 months thereafter for up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Maximum observed plasma concentration of PF-06801591 (Cmax) |
Time Frame: | Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Time to maximum concentration of PF-06801591 (Tmax) |
Time Frame: | Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Area under the curve from time zero extrapolated to infinity of PF-06801591 |
Time Frame: | Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Trough concentrations after multiple doses of PF-06801591 (Ctrough) |
Time Frame: | Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Pfizer |
Last Updated
March 9, 2021