Moffitt Cancer Center: Clinical Trial 20300

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Clinical Trial 20300

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT03834506

Phase: Phase III
Prinicipal Investigator: Julie Kish

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone versus Placebo Plus Docetaxel Plus Prednisone in Participants with Chemotherapy-naive Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE- 921)

Summary

The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).

Objective

Primary Objectives: To compare pembrolizumab plus docetaxel plus prednisone to placebo plus docetaxel plus prednisone with respect to overall survival. - To compare pembrolizumab plus docetaxel plus prednisone to placebo plus docetaxel plus prednisone with respect to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)- modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). Secondary Objective: - To compare pembrolizumab plus docetaxel plus prednisone to placebo plus docetaxel plus prednisone with respect to time to initiation of the first subsequent anti-cancer therapy or death (TFST) - To evaluate pembrolizumab plus docetaxel plus prednisone versus placebo plus docetaxel plus prednisone with respect to PSA response rate Objective response rate (ORR) and the duration of response (DOR) per PCWG-modified RECIST 1.1 as assessed by BICR

Treatments

Therapies

Medications

Dexamethasone (); Pembrolizumab (Keytruda); Placebo (); Taxotere (docetaxel); docetaxel (); prednisone ()

Inclusion Criteria

> Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology

Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening

Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)

Has received prior treatment with either abiraterone acetate or enzalutamide (but not both) in the pre-chemotherapy mCRPC state and either a) progressed through treatment OR b) has become intolerant of the drug

Has ongoing androgen deprivation with serum testosterone > Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization

Participants must agree to the following during the study treatment period and for at least 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)

Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex

Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization

Exclusion Criteria

> Has a known additional malignancy that is progressing or has required active treatment in the last 3 years

Has an active autoimmune disease that has required systemic treatment in past 2 years

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy

Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications

Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules

Has an active infection (including tuberculosis) requiring systemic therapy

Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients

Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)

Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs

Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto) prior to randomization

Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer

Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)

Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC

Has hypersensitivity to docetaxel or polysorbate 80

Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study

Has had prior treatment with one or more next generation hormonal agents (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer or non-metastatic castrate resistant prostate cancer and progressed on this treatment

Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment, or has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent

Has received prior radiotherapy to within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis

Has received a live vaccine within 30 days prior to randomization

Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to randomization

Has received prior treatment with ketoconazole for prostate cancer

Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

Has a "superscan" bone scan

Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment

Has had an allogenic tissue/solid organ transplant

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.