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Triple Therapy for Bladder Cancer
Phase 2
Recruiting
Led By Omar Alhalabi, MD
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
Prior anti-PD-1/PD-L1 therapy is mandatory
Patients must have histologic confirmation of MTAP-deficient metastatic urothelial carcinoma. MTAP-deficiency must be verified by institutional CLIA-certified IHC or by Next gen sequencing showing copy number loss of MTAP gene. Histological variants such as glandular, squamous, sarcomatoid, micropapillary, plasmacytoid, and small cell changes will be allowed for this trial if these tumors are MTAP-deficient.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is for patients with MTAP-deficient advanced urothelial cancer who have received prior immunotherapy. It is a single site study at the University of Texas MD Anderson Cancer Center. This study will allow patients in second line of treatment for advanced urothelial cancer or beyond.
Who is the study for?
Adults with MTAP-deficient advanced urothelial cancer who've had prior immunotherapy can join this Phase 2 trial. They must have measurable disease, adequate organ function, and an ECOG performance status ≤ 2. Pregnant women, those with certain heart conditions or severe allergies to antibodies, and individuals with uncontrolled illnesses are excluded.Check my eligibility
What is being tested?
The study tests a combination of Pemetrexed plus AB928 (Etrumadenant) & AB122 (Zimberelimab) in patients previously treated for advanced bladder cancer. It's open-label at MD Anderson Cancer Center and includes participants as second-line treatment or beyond.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in various organs, infusion-related reactions from the drugs administered, fatigue, possible liver enzyme elevations indicating liver stress or damage, blood cell count changes which could affect immunity and healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have previously received anti-PD-1/PD-L1 therapy.
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My cancer is confirmed to lack MTAP and has spread.
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My cancer can be measured and is large enough for a biopsy.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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My kidney function is normal or meets the minimum required levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 and Number of Participants With Complete or Partial Response as their Best Overall Response per RECIST v1.1.
Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pemetrexed Plus AB928 (Etrumadenant) Plus AB122 (Zimberelimab)Experimental Treatment3 Interventions
All patients will receive combination therapy of pemetrexed and ZIMBERELIMAB (AB122) intravenously every 3 weeks as well as ETRUMADENANT (AB928) orally daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
FDA approved
Zimberelimab
2018
Completed Phase 1
~50
Etrumadenant
2018
Completed Phase 1
~130
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,301 Total Patients Enrolled
Omar Alhalabi, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any live vaccines in the last 4 weeks and will not while on the trial, except for the COVID-19 vaccine.I have tested positive for HIV/AIDS.I have a mild or well-controlled autoimmune condition that doesn't majorly affect my immune system.I haven't taken high doses of steroids or immunosuppressants in the last 2 weeks.I do not have any serious ongoing illnesses like heart problems or lung disease.I have had an organ or stem-cell transplant in the past.I have previously received anti-PD-1/PD-L1 therapy.My cancer is mainly in my bones but can be measured or seen as a mass.I haven't taken strong medication or substances that affect liver enzymes in the last month.I have fluid buildup that can't be managed with drainage.I haven't had major surgery or am still recovering from one within the last 28 days.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.My cancer is confirmed to lack MTAP and has spread.I am eligible for treatment beyond my first after immunotherapy.My cancer can be measured and is large enough for a biopsy.I stopped checkpoint therapy due to severe side effects.I will use effective birth control or abstain from sex during and after the study as required.I have been treated with drugs targeting the adenosine pathway.I do not have active inflammatory bowel disease or autoimmune disorders.I can take care of myself but might not be able to do heavy physical work.I have received antifolate therapy before for cancer.My liver tests are within the required range, even with liver metastases.I am a woman able to have children and have a recent negative pregnancy test.I am 18 years old or older.My blood tests show enough white cells, hemoglobin, and platelets.My kidney function is normal or meets the minimum required levels.I haven't taken any specific heart medication orally within the last 4 weeks or 5 half-lives.I do not have brain cancer or cancer that has spread to my brain, or if I had, it's been stable for 4 weeks without steroids.I can take oral medications without issues like swallowing difficulty or severe nausea.I have not taken any medication that could interact with etrumadenant.I can stop taking NSAIDs as required and follow the vitamin and medication regimen.I have been cancer-free for over 2 years, except for certain low-risk types.I am currently receiving dialysis.I haven't taken specific heart or cholesterol medications orally within the last 4 weeks or 5 half-lives.
Research Study Groups:
This trial has the following groups:- Group 1: Pemetrexed Plus AB928 (Etrumadenant) Plus AB122 (Zimberelimab)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
What are the dangers of Pemetrexed for people?
"Although there is some evidence pointing to its safety, Pemetrexed only received a score of 2 because this is still classified as a Phase 2 trial. This means that while there are no studies currently supporting efficacy, animal testing has shown some promise."
Answered by AI
Are we still looking for people to participate in this experiment?
"According to the latest information available on clinicaltrials.gov, this study is not recruiting patients at the moment. The trial was originally posted on September 30th, 2022 and was last updated on August 31st, 2022. Although this particular clinical trial isn't looking for candidates, there are 2756 other trials that are actively recruiting participants right now."
Answered by AI
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