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

MacroGenics

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: docetaxel; Drug: Prednisone; Biological: lorigerlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05848011

CP-MGD019-02

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Lorigerlimab + Docetaxel and Prednisone

Experimental group

Description:

Lorigerlimab 6 mg/kg IV (up to 2 years) and docetaxel 75 mg/m\^2 IV every 3 weeks (up to 7 months) and prednisone 5 mg orally twice daily (up to 7 months).

Treatment:

Biological: lorigerlimab

Drug: Prednisone

Drug: docetaxel

Standard of care docetaxel and prednisone

Other group

Description:

Docetaxel 75 mg/m\^2 IV every 3 weeks and prednisone 5 mg orally twice daily.(up to 7 months)

Treatment:

Drug: Prednisone

Drug: docetaxel