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Checkpoint Inhibitor

Immunotherapy for Prostate Cancer (IMPACT Trial)

Phase 2
Waitlist Available
Led By Ajjai Alva, MD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with prostate cancer must have ongoing androgen deprivation with total serum testosterone < 50 ng/dL
Subjects must have a histologic or cytologic diagnosis of metastatic adenocarcinoma of the prostate without small cell histology OR another type of metastatic carcinoma
Must not have
Treatment with any investigational agent or on an interventional clinical trial within 28 days prior to registration
Any history of organ allografts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether a immunotherapy drug combo can help treat prostate cancer, specifically in patients with a loss of CDK12 function.

Who is the study for?
Adults over 18 with metastatic prostate or other cancers and CDK12 mutations can join. They must have a performance status of 0-2, measurable cancer progression, and adequate organ function. Women must not be pregnant and all participants should agree to contraception. Exclusions include recent trial participation, organ transplants, certain infections, prior immunotherapy treatments, need for high-dose steroids or having autoimmune diseases.
What is being tested?
The trial is testing the effectiveness of nivolumab alone and combined with ipilimumab in treating metastatic cancers with CDK12 loss. It starts with both drugs together followed by just nivolumab for patients with prostate cancer and similar treatment for those with other solid tumors.
What are the potential side effects?
Nivolumab and ipilimumab may cause immune-related side effects like inflammation in various organs (e.g., lungs or intestines), skin rash, hormone gland problems (like thyroid issues), fatigue, infusion reactions (symptoms related to the administration of these drugs), as well as potential liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on hormone therapy for prostate cancer with low testosterone levels.
Select...
My cancer is a type of prostate cancer that has spread, but it's not small cell cancer.
Select...
My cancer can be measured on scans and is not prostate cancer.
Select...
My prostate cancer has worsened in the last 6 months, shown by rising PSA levels.
Select...
My cancer has a CDK12 mutation.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't been part of a clinical trial or taken experimental drugs in the last 28 days.
Select...
I have had an organ transplant.
Select...
I require more than 10mg of prednisone daily or similar medication, not including adrenal replacement therapy.
Select...
I have not been treated with anti-PD-1/PD-L1 or anti-CTLA-4.
Select...
I have a history of HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Proportion of Patients With CDK12 Loss of Function Metastatic CRPC That Respond to Treatment.
Secondary study objectives
Duration of Therapy (DOT)
Overall Survival Time
PSA Progression Free Survival Time
+5 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Solid Tumors (non-prostate)Experimental Treatment2 Interventions
Patients with all other metastatic subtypes will be enrolled in cohort B
Group II: Metastatic CRPC with MonotherapyExperimental Treatment1 Intervention
Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed.
Group III: Metastatic CRPCExperimental Treatment2 Interventions
Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220
Ipilimumab
2014
Completed Phase 3
~3140

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
24,228 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterOTHER
1,965 Previous Clinical Trials
596,927 Total Patients Enrolled
University of California, San FranciscoOTHER
2,583 Previous Clinical Trials
15,084,010 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03570619 — Phase 2
Cancer Research Study Groups: Solid Tumors (non-prostate), Metastatic CRPC with Monotherapy, Metastatic CRPC
Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03570619 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03570619 — Phase 2
~8 spots leftby Nov 2025
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