PROSTATE: METASTATIC: 2nd line or greater: Pembro/Vibostolimab: KEYNOTE-365 ARM G

Study snapshot

Title: Merck Prostate KEYNOTE 365 ARM G
Malignancy: Prostate
Stage: Stage 4
Disease setting: Metastatic/Palliative
Line of therapy: 2nd line or greater
Investigational agent: Pembrolizumab Vibostolimab coformulation
Drug class: PD-1 inhibitor + Anti-TIGIT
Principal investigator: Dan Vaena, MD
Sponsor: Merck Sharp and Dohme
Path: Adenocarcinoma
Randomized: No
ClinicalTrials.gov ID: NCT02861573

Eligibility and objectives

Key eligibility criteria details

Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Must provide a core or excisional biopsy from soft tissue or bone biopsy within 1 year of screening and after developing mCRPC. Participants with bone metastasis only must provide an archival tumor tissue specimen.
Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on RECIST criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
Patients receiving bone resorptive therapy must be on stable doses
ECOG PS 0-1
Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide or other next-generation hormonal agents [NHA]) are allowed. Participants who received prior ketoconazole for metastatic disease may be enrolled. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy. Prior docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC) is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to Day 1 of Cycle 1
No immunodeficiency or systemic steroid use
No active autoimmune disease within 2 years
No known HIV/HBV/HCV
No known CNS mets
No superscan bone scan
No symptomatic ascites or pleural effusion

Objective

Primary
- Percentage of patients with PSA decrease of >/= 50%
- AEs
- ORR
Secondary
- DCR
- OS
- DOR
- ORR by PCWG3-modified RECIST
- Time to PSA progression
- Radiographic PFS
- Composite response rate (PFS, PSA)

Study snapshot

Eligibility and objectives

Key eligibility criteria details

Objective

Treatment details