Phase
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Urologic Cancer
Treatment
Lutetium Lu-177 vipivotide tetraxetan
Pasritamig
Cetrelimab
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part 1 A-G, 1I, 1J, and 1K (all combination treatments) and Parts 2B-C (cabazitaxel,docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmedadenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G, 2I, 2J, and 2K (apalutamide, enzalutamide, darolutamide,abiraterone acetate + prednisone [AAP], lutetium Lu-177 vipivotide tetraxetan,JNJ-101556143): mCRPC: Histologically confirmed adenocarcinoma of the prostate asdefined by PCWG3, with a minimum PSA of 2 nanogram [ng]/milliliter (mL); Part 2H (apalutamide): metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greaterthan (>) 0.2 ng/mL on 6 to 24 months of treatment with a next generation ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone)
Measurable or evaluable disease, except for Part 2H
(a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgenreceptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide,enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G, 2G (AAP), and Part 1K & 2K (JNJ-101556143)- Priortreatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide,darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Priortreatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide,enzalutamide, darolutamide) and docetaxel. (d) Part 2D (apalutamide) - Priortreatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant may havereceived up to 6 cycles of docetaxel. The last dose of docetaxel must beadministered at least 2 months prior to enrollment (f) Parts 1I, 1J, 2I & 2J (lutetium Lu-177 vipivotide tetraxetan)- Prior treatment with at least 1 ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide). Participant mustnot have received prior cytotoxic chemotherapy or prior radioligand therapy (RLT)for mCRPC
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ functions
Exclusion
Exclusion Criteria:
Active autoimmune disease within the 12 months prior to signing consent thatrequires systemic immunosuppressive medications
Toxicity related to prior anticancer therapy that has not returned to Grade lessthan or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2peripheral neuropathy)
Solid organ or bone marrow transplantation
Known allergies, or intolerance to any of the components (example, excipients) ofpasritamig, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1Cand 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E),darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G), lutetium Lu-177 vipivotidetetraxetan (Parts 1I, 1J, 2I, and 2J), or JNJ-101556143 (Parts 1K & 2K)
Significant infections or serious lung, heart or other medical conditions
Study Design
Connect with a study center
Icon Cancer Centre Kurralta Park
Kurralta Park, 5037
AustraliaActive - Recruiting
Icon Cancer Centre Kurralta Park
Kurralta Park 8348005, 5037
AustraliaSite Not Available
Macquarie University
Macquarie University, 2109
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, 3000
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne 2158177, 3000
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, 4102
AustraliaActive - Recruiting
Princess Alexandra Hospital
Woolloongabba 6943568, 4102
AustraliaSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Hosp Univ Vall D Hebron
Barcelona, 8035
SpainActive - Recruiting
Hosp Univ Vall D Hebron
Barcelona 3128760, 8035
SpainSite Not Available
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Hosp Univ Hm Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid 3117735, 28040
SpainActive - Recruiting
Hosp Univ Hm Sanchinarro
Madrid 3117735, 28050
SpainSite Not Available
Hosp. Univ. 12 de Octubre
Madrid 3117735, 28041
SpainActive - Recruiting
Florida Cancer Specialists
Sarasota, Florida 34232
United StatesActive - Recruiting
Florida Cancer Specialists
Sarasota 4172131, Florida 4155751 34232
United StatesSite Not Available
Start Midwest
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
Start Midwest
Grand Rapids 4994358, Michigan 5001836 49546
United StatesSite Not Available
Washington University School Of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School Of Medicine
St Louis, Missouri 63110
United StatesActive - Recruiting
Washington University School Of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Perlmutter Cancer Center at NYU Langone Brooklyn
Brooklyn, New York 11223
United StatesActive - Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Perlmutter Cancer Center at NYU Langone Brooklyn
Brooklyn 5110302, New York 5128638 11223
United StatesSite Not Available
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638 11501
United StatesSite Not Available
NYU Langone Health
New York 5128581, New York 5128638 10016
United StatesSite Not Available
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available

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