Phase 2 INSPIRE trial: Ipilimumab with Nivolumab in molecular-selected patients with castration-resistant prostate cancer - INSPIRE

Radboudumc0 sites75 target enrollmentJuly 2, 2020

Conditions(metastatic) castration-resistant prostate cancer Therapeutic area: Diseases [C] - Cancer [C04]

DrugsOpdivo Yervoy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: (metastatic) castration-resistant prostate cancer
Sponsor: Radboudumc
Enrollment: 75
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 2, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Radboudumc

Eligibility Criteria

Inclusion Criteria

•1\. Written informed consent.
•2\. Histological diagnosis of adenocarcinoma of the prostate. Patients who have no histological diagnosis must be willing to undergo a biopsy to prove prostate adenocarcinoma.
•3\. Metastatic Castration\-Resistant Prostate Cancer (mCRPC), metastatic disease defined either by measurable disease by RECIST1\.1 criteria and/or presence of bone\-metastatic disease evaluable per PCWG3 criteria. For cohort 1, measurable disease is compulsory.
•4\. An immunogenic phenotype, consisting of one of the next criteria:
•1, mismatch repair deficiency and/or a high mutational burden of \>10 mutations per Mb (cluster A);
•2, BRCA2 inactivation and/or BRCAness signature (cluster B);
•3, a tandem duplication signature (cluster C).
•5\. Age \=18 years.
•6\. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 – 1\.
•7\. PSA \= 2 ng/ml.

Exclusion Criteria

•1\. Prior treatment with checkpoint immunotherapy (CTLA\-4, or PD\-1 and PD\-L1 antagonists) for cohort 1\. For cohort 2 patients may have prior treatment with monotherapy CTLA\-4 or PD\-1 or PD\-L1\.
•2\. Surgery, chemotherapy within 4 weeks prior to trial entry / randomisation into the study. Any other therapies for prostate cancer, other than GnRH analogue therapy and osteoporosis preventing agents, are not allowed.
•3\. Radiotherapy within 2 weeks prior to trial entry. Radiation\-related side effects higher than grade 1, or above baseline.
•4\. Participation in another interventional clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry / randomisation.
•5\. History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumours, brain metastases, or alcoholism.
•6\. Untreated or symptomatic brain or leptomeningeal involvement.
•7\. Inadequate organ and bone marrow function as evidenced by: a. haemoglobin \<6\.2 mmol/L b. Absolute neutrophil count \<1\.0 x 109/L c. Platelet count \< 75 x 109/L d. Albumin \<30 g/dL. e. AST / SGOT and/or ALT / SGPT \= 2\.5 x ULN (\= 5 x ULN if liver metastases present) f. Total bilirubin \= 1\.5 x ULN (except for patient with documented Gilbert’s disease) g. Serum Creatinine \> 1\.5 x ULN
•8\. Any of the following cardiac criteria; a. Any clinically significant abnormalities in rhythm, conduction, or morphology of a resting ECG (e.g., complete left bundle branch block, third degree heart block)
•c. Experience of any of the following procedures or conditions in the preceding six months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, congestive heart failure NYHA \= Grade2
•d. Uncontrolled hypotension defined as – systolic blood pressure (BP) \<90mmHg and/or diastolic BP \<50mmHg