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Enzyme Inhibitor
Valemetostat + Ipilimumab for Metastatic Prostate, Urothelial, and Renal Cell Cancers
Phase 1
Recruiting
Led By Ana Aparicio
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with prostate carcinomas must also display the AVPC molecular signature (i.e. known loss or mutation [by Clinical Laboratory Improvement Act (CLIA) certified molecular testing by immunohistochemistry (IHC) and/or deoxyribonucleic acid (DNA) sequencing in solid tumor samples, and/or in circulating tumor DNA]) in at least 2 of the following: Tp53, RB1 and PTEN
Ability to swallow and retain oral medications
Must not have
Myocardial infarction (MI)/stroke within 6 months prior to day 1 of study treatment
Clinically significant cardiovascular disease including:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests DS3201 and ipilimumab together for patients with advanced prostate, urothelial, or renal cell cancer. DS3201 blocks enzymes to stop cancer growth, while ipilimumab boosts the immune system to fight cancer. The goal is to find the best dose and check for side effects.
Who is the study for?
This trial is for adults with metastatic prostate, urothelial, or renal cell cancers who have an ECOG performance status of 0-1. They must have confirmed cancer spread and be recovered from previous treatments. Eligible participants need proper organ function and no active infections like hepatitis or HIV. Pregnant women, those with certain heart conditions or autoimmune diseases, and individuals on recent cancer therapies are excluded.
What is being tested?
The trial tests the combination of DS3201 (Valemetostat) and Ipilimumab to determine safe dosages and side effects in treating advanced cancers. Valemetostat targets enzymes for tumor growth while Ipilimumab boosts the immune system's ability to fight cancer cells.
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, skin issues, hormonal imbalances, digestive disturbances, fatigue, infusion-related reactions and increased susceptibility to infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer shows specific genetic changes in Tp53, RB1, or PTEN.
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I can swallow and keep down pills.
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My kidney cancer worsened despite treatment with specific cancer drugs.
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My cancer is visible on scans and can be biopsied.
Select...
I am fully active or can carry out light work.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My cancer has grown or spread according to recent scans.
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My brain metastases are stable, and I've been off steroids or on a low dose for 4 weeks without neurological issues.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a heart attack or stroke in the last 6 months.
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I have a serious heart condition.
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I have a history of lung scarring or inflammation.
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I do not have an active hepatitis B or C infection.
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My cancer has spread to the lining of my brain and spinal cord.
Select...
I have untreated spinal cord or brain issues due to cancer.
Select...
My heart test (ECG) does not show major issues that could affect my safety in the study.
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I have a history of serious irregular heartbeats.
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I have been treated with an EZH2 inhibitor before.
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I have a GI condition that affects how my body absorbs nutrients.
Select...
I stopped my immunotherapy permanently due to a severe side effect.
Select...
I have severe heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Secondary study objectives
Immunologic and molecular effects
Overall response rate (ORR)
Time to treatment failure (TTF)
Side effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
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
1Treatment groups
Experimental Treatment
Group I: Treatment (valemetostat, ipilimumab)Experimental Treatment2 Interventions
Patients receive valemetostat PO QD on days 1-21 and ipilimumab IV over 90 minutes on day 1 of cycles 1 and 3. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~3140
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer include enzyme inhibition and immune system activation. Enzyme inhibitors, like DS3201, block specific enzymes needed for tumor cell growth, preventing cancer proliferation.
Immune system activators, such as ipilimumab, use monoclonal antibodies to enhance the body's immune response by blocking checkpoints like CTLA-4, allowing T-cells to attack cancer cells more effectively. These targeted approaches are vital for prostate cancer patients as they help control disease progression and improve outcomes.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,144 Total Patients Enrolled
88 Trials studying Prostate Cancer
28,628 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,385 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
Ana AparicioPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
341 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack or stroke in the last 6 months.I have a serious heart condition.Your liver enzyme levels must be within a certain range, depending on whether you have liver cancer that has spread or not.You have a known history of HIV infection.My blood pressure is controlled with medication.I have an autoimmune disease but it's under control or not expected to worsen without an external trigger.My scans show cancer has spread and cannot be treated with surgery or radiation.Your hemoglobin level is at least 9 grams per deciliter.I need daily medication for chronic conditions, but not just local treatments like creams or inhalers.I have a history of lung scarring or inflammation.My prostate cancer shows specific genetic changes in Tp53, RB1, or PTEN.Your blood test showed that you have enough albumin in your blood.I haven't taken any monoclonal antibody treatments in the last 4 weeks.I do not have an active hepatitis B or C infection.Your bilirubin level should be within a certain range, unless you have Gilbert's disease.My prostate cancer is worsening, shown by increasing PSA levels.I can swallow and keep down pills.My cancer has spread to the lining of my brain and spinal cord.I have not taken any experimental drugs in the last 2 weeks.I have not used specific anti-cancer agents listed in the criteria.I have untreated spinal cord or brain issues due to cancer.My kidney cancer worsened despite treatment with specific cancer drugs.My cancer is visible on scans and can be biopsied.My cancer is confirmed to be prostate, bladder, or kidney cancer.I am a woman who can have children and have a recent negative pregnancy test.I had a severe reaction to previous immunotherapy but my hormone-related side effects are under control.I do not have another cancer that is getting worse or needs treatment soon.My heart test (ECG) does not show major issues that could affect my safety in the study.I do not have any severe health issues that could affect my participation in the study.I agree to use highly effective birth control during and 3 months after treatment.I have recovered from recent cancer treatments with minimal side effects.I have a history of serious irregular heartbeats.I have been treated with an EZH2 inhibitor before.I haven't had radiation or radionuclide therapy in the last 2 weeks.I am fully active or can carry out light work.I have not received a live virus vaccine in the last 30 days.I have a GI condition that affects how my body absorbs nutrients.My kidney function, measured by creatinine levels or clearance, is within the required range.I stopped my immunotherapy permanently due to a severe side effect.I can understand and am willing to sign a consent form for my health information, including genetic testing, to be released.I haven't had chemotherapy in the last 2 weeks.My prostate cancer is resistant to hormone therapy.I am willing and able to follow the study's requirements.I haven't taken any PD-1, PD-L1, PD-L2, or CTLA-4 inhibitors in the last 4 weeks.My cancer has grown or spread according to recent scans.I have not had unstable chest pain in the last 3 months.I have severe heart failure.Your white blood cell count is at least 1,500 per microliter within the last 28 days before starting the treatment.Your blood platelet count is at least 100,000 per microliter within the last 28 days before starting treatment.My bladder cancer worsened after treatment with specific immune therapies and I've had or can't have platinum-based chemotherapy.My brain metastases are stable, and I've been off steroids or on a low dose for 4 weeks without neurological issues.Your liver enzyme levels must be within a certain range before starting the treatment. If you have liver cancer that has spread, the levels must be within a different range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (valemetostat, ipilimumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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