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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of DS3201 when given with ipilimumab to treat patients with metastatic prostate, urothelial, or renal cell cancer. DS3201 may stop tumor cell growth by blocking some enzymes needed for cell growth. Immunotherapy with monoclonal antibodies like ipilimumab may help the body's immune system attack the cancer and interfere with the ability of tumor cells to grow and spread. Giving DS3201 and ipilimumab may help control the disease.
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.Check my eligibility
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.See study design
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.
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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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum tolerated dose
Secondary outcome measures
Immunologic and molecular effects
Overall response rate (ORR)
Time to treatment failure (TTF)
Side effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
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
~2620
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,310 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,774 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are taking part in this trial?
"Affirmative. Clinicaltrials.gov attests that this investigation, which was first uploaded on August 20th 2020, is actively looking for candidates. 80 individuals are required to be recruited from a solitary medical center."
Answered by AI
What conditions usually necessitate a prescription of Valemetostat?
"Valemetostat is frequently prescribed for the care of cutaneous melanoma. It can also be employed to address conditions such as complete resection, liver carcinoma, and metastatic melanoma."
Answered by AI
Does this research have active recruitment for participants?
"Clinicaltrials.gov confirms that this medical trial is open for enrollment, having been posted on August 20th 2020 and last updated on October 31st 2022."
Answered by AI
Has Valemetostat been accredited by the FDA?
"Due to the limited clinical data available for Valemetostat, our team at Power assigned it a safety rating of 1. This drug is currently undergoing Phase 1 trials, suggesting that its efficacy and risks are still largely unknown."
Answered by AI
What other experiments have been completed related to Valemetostat?
"At present, 318 clinical trials featuring Valemetostat are in operation. Of these 38 studies are in their final phase of development. Most research is being conducted out of Pittsburgh but there exist a total 20370 sites running experiments with this medication."
Answered by AI
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