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EVOLUTION: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC

NCT05150236 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2023-12-15

No results posted yet for this study

Summary

This phase II study will investigate the activity and safety of radionuclide 177Lu-PSMA therapy versus 177Lu-PSMA in combination with Ipilimumab and Nivolumab in patients with metastatic castrate resistant prostate cancer (mCRPC).

Conditions

  • Prostatic Neoplasms
  • Genital Neoplasms, Male
  • Urogenital Neoplasms
  • Prostate Cancer
  • Neoplasms by Site
  • Neoplasms
  • Prostatic Disease

Interventions

DRUG

177Lu-PSMA-617

Patients will be given 7.5GBq of Lu-PSMA every 6 weeks up to 6 cycles unless there is unacceptable toxicity, commencing following result of 68Ga-PSMA PET within 28 days of registration.

DRUG

Ipilimumab

Patients will be given 3mg/kg of Ipilimumab every 6 weeks up to 4 doses unless there is unacceptable toxicity, concurrently with Lu-PSMA and Nivolumab.

DRUG

Nivolumab

Patients will be given 1mg/kg of Nivolumab every 3 weeks up to 8 doses, concurrently with Lu-PSMA and Ipilimumab unless there is unacceptable toxicity. Followed by 480mg nivolumab monotherapy commencing at week 32. Nivolumab monotherapy will be given to patients every 4 weeks up to 18 doses, or until disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • Prostate Cancer Foundation of Australia

    collaborator UNKNOWN

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Advanced Accelerator Applications

    collaborator INDUSTRY

  • University of Sydney

    collaborator OTHER

  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group

    lead OTHER

Principal Investigators

  • Shahneen Sandhu, MBBS, FRACP · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-29
Primary Completion
2024-08-31
Completion
2024-12-31

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05150236 on ClinicalTrials.gov