A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

Clinicaltrials.gov ID: NCT05848011

Status RECRUITING

Phase PHASE2

Age ≥ 18 Years

Enrollments 150

Conditions

Androgen-Independent Prostatic Cancer, Androgen-Independent Prostatic Neoplasms, Prostate Cancer Recurrent, Androgen-Insensitive Prostatic Cance, Androgen-Resistant Prostatic Cancer, Hormone Refractory Prostatic Cancer, Immunotherapy, Immune Checkpoint Inhibitor, Inhibitory Checkpoint Molecule

Drugs

docetaxel, Prednisone

Summary

The purpose of this study is to determine whether the amount of time before disease progression can be prolonged in participants with metastatic castration-resistant prostate cancer (MCRPC) who receive lorigerlimab in addition to the standard of care (SOC) of docetaxel and prednisone. About 150 participants with mCRPC will be enrolled. Participants will be randomized in a 2:1 ratio to receive lorigerlimab with docetaxel and prednisone (experimental arm) or docetaxel and prednisone alone (standard-of-care arm).Lorigerlimab+docetaxel or docetaxel will be administered intravenously (IV) in clinic on Day 1 of each 3-week cycle. Prednisone will be administered orally twice daily. Lorigerlimab will be administered for up to 35 cycles. Docetaxel and prednisone will be administered up to 10 cycles until treatment discontinuation criteria are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI) and prostate-specific antigen (PSA) blood tests. Participants will be asked to complete questionnaires about their health and well-being. Routine examinations and blood tests will be performed and evaluated by the study doctor.Participants who have disease progression standard-of-care arm have the option of continuing on the study to receive lorigerlimab monotherapy.

Locations

9 locations Found with status Recruiting

Status

RECRUITING

Contact Person

Hatem Hassanein

Study Director

Denise Casey, M.D.

Status

RECRUITING

Contact Person

Daniel Fein

Study Director

Denise Casey, M.D.

Status

RECRUITING

Contact Person

Xiao Wei

Study Director

Denise Casey, M.D.

Status

RECRUITING

Contact Person

Ralph Hauke, MD, FACP

Study Director

Denise Casey, M.D.

Status

RECRUITING

Contact Person

Ashutosh Tewari

Study Director

Denise Casey, M.D.

Status

RECRUITING

Contact Person

Alina Basnet

Study Director

Denise Casey, M.D.

Status

RECRUITING

Contact Person

Sumit Subudhi

Study Director

Denise Casey, M.D.

Status

RECRUITING

Contact Person

Joseph Call, MD

Study Director

Denise Casey, M.D.

Status

RECRUITING

Contact Person

William Skelton

Study Director

Denise Casey, M.D.

Eligibility Criteria

Inclusion Criteria:

* Metastatic castration-resistant adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
* Participants must have ≥ 1 metastatic (measurable or non-measurable per PCWG3) lesion.
* Participant has prostate cancer progression at study entry based on PCWG3 criteria.
* Participant shows evidence of disease progression after receiving at least 1 prior androgen receptor axis-targeted therapy (ARAT) regimen (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide).
* Patients with known history of documented breast cancer gene (BRCA) mutation (germline or somatic) must have received an approved poly ADP ribose polymerase (PARP) inhibitor regimen.
* Participants must have adequate performance status, life expectancy and laboratory values.

Exclusion Criteria:

* Any condition preventing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
* Received prior chemotherapy for mCRPC or checkpoint inhibitors for prostate cancer.
* Current active or chronic infections.
* Any clinically significant heart, lung, or gastrointestinal disorders.
* Allergy to any of the study treatments or components of the study treatments.

Outcome Measures

Primary Outcome Measures

Median radiographic progression free survival (rPFS) determined by investigator review.

Time Frame: Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years

Secondary Outcome Measures

Objective response rate (ORR) per PCWG3 criteria

Time Frame: Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years

Duration of response (DoR)

Time Frame: Every 9 weeks for the first year, then every 12 weeks for up to 4 years

Time to response (TTR)

Time Frame: Every 9 weeks for the first year, followed by every 12 weeks for up to 3 more years

PSA50 response rate

Time Frame: Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years

PSA90 response rate

Time Frame: Every 3 weeks up to 2 years, followed by every 12 weeks for up to 2 more years

Time to PSA progression

Time Frame: Every 9 weeks for the first year, followed by every 12 weeks for up to 2 more years

Duration of PSA response

Time Frame: Every 3 weeks up to 2 years, followed by every 23 weeks for up to 2 more years.

Overall survival (OS)

Time Frame: Throughout the study up to 4 years

Time to First Symptomatic Skeletal Event (SSE)

Time Frame: Throughout the study up to 4 years

Time to pain progression using the BPI-sf questionnaire

Time Frame: Every 9 weeks for the first year, followed by every 12 weeks for up to 2 more years

Pain severity using the Brief Pain Index - short form (BPI-sf) questionnaire

Time Frame: Every 3 weeks up to 2 years

Pain interference using the BPI-sf questionnaire

Time Frame: Every 3 weeks up to 2 years

Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire

Time Frame: Every 3 weeks up to 2 years