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Monoclonal Antibodies
Pemetrexed + Avelumab for Bladder Cancer
Phase 2
Waitlist Available
Led By Amishi Y Shah
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
Normal serum creatinine, or a creatinine clearance >= 40 ml/min [either measured using a 24 hour urine, calculated using Cockcroft-Gault, or estimated using the MDRD method from the National Kidney Disease Education Program (NKDEP) (the method reported by MD Anderson Cancer Center [MDACC] laboratories).
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the trial entry to the first documented tumor progression as determined by the investigator using the recist v1.1 criteria or death from any cause, whichever occurs first, assessed up to 2 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat urothelial cancer that has spread. Pemetrexed may stop tumor cell growth by blocking enzymes needed for cell growth. Avelumab is an immunotherapy that may help the body's immune system attack the cancer, and may stop tumor cells from growing and spreading.
Who is the study for?
This trial is for adults with MTAP-deficient metastatic urothelial cancer, who can stop NSAIDs as required, have measurable disease, normal organ function tests, and no severe autoimmune diseases. Participants must not be pregnant or breastfeeding and agree to use effective contraception.Check my eligibility
What is being tested?
The study examines the effectiveness of combining pemetrexed (a drug that blocks enzymes needed for cell growth) with avelumab (an immunotherapy antibody) in treating patients whose cancer has spread beyond the bladder.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, nausea, blood count changes which could increase infection risk. Specific side effects will vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is normal or nearly normal.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from the trial entry to the first documented tumor progression as determined by the investigator using the recist v1.1 criteria or death from any cause, whichever occurs first, assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the trial entry to the first documented tumor progression as determined by the investigator using the recist v1.1 criteria or death from any cause, whichever occurs first, assessed 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
Overall response rate
Secondary outcome measures
Overall survival
Progression free survival
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%
Cerebral infarction
1%
Ischaemic stroke
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: Treatment (pemetrexed, avelumab)Experimental Treatment2 Interventions
Patients receive pemetrexed IV over 10 minutes on day 1. Starting cycle 2, patients also receive avelumab IV over 60 minutes. 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
Avelumab
2018
Completed Phase 2
~2450
Pemetrexed
2014
Completed Phase 3
~5250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,305 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,763 Total Patients Enrolled
Amishi Y ShahPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a mild or well-controlled autoimmune condition that doesn't majorly affect my immune system.I can stop taking NSAIDs as required around my pemetrexed treatment.My cancer can be measured and biopsied according to specific guidelines.I haven't taken high doses of steroids or immunosuppressants in the last 2 weeks.I am using or willing to use effective birth control and won't donate eggs for 6 months after the last dose.I have not had major surgery or am fully recovered if I did within the last 28 days.I am eligible for my second or third cancer treatment after specific prior treatments.I am a man who can father children and will use effective birth control for 6 months after my last dose.I do not have autoimmune diseases like Crohn's, lupus, or rheumatoid arthritis.I have had an organ or stem-cell transplant in the past.I can take folic acid, vitamin B12, and dexamethasone as required.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I had chemotherapy with methotrexate over a year ago.I have side effects from past treatments, but they are mild and not dangerous.My cancer is confirmed to lack MTAP and has spread, as tested by a certified lab.My kidney function is normal or nearly normal.I haven't had any vaccines in the last 4 weeks and won't get any during the trial, except for inactivated ones.I have fluid buildup that can't be managed with drainage.I can take care of myself and am up and about more than half of my waking hours.I have been cancer-free for at least 2 years, except for certain skin, prostate cancers, or in situ carcinoma.I do not have any severe ongoing illnesses like heart problems or lung diseases.I do not have brain cancer or cancer that has spread to my brain, or if I do, it has been stable for at least 4 weeks without needing steroids.I have tested positive for HIV/AIDS.I have not had a recent serious heart or stroke issue.I am currently receiving dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pemetrexed, avelumab)
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.
Has the federal government given clearance to Pemetrexed?
"Our team at Power has assigned Pemetrexed a rating of 2, as Phase 2 trials have yielded evidence of safety but no confirmation that the intervention is effective."
Answered by AI
What conditions is Pemetrexed typically prescribed to address?
"Pemetrexed is regularly utilized to combat cancerous growths. It has also been clinically documented as a viable treatment for ovarian cancer, advanced directives, and unresectable thymoma cases."
Answered by AI
Are there still vacancies available for those wishing to participate in this experiment?
"Unfortunately, the clinical trial's details listed on clinicaltrials.gov suggests that it is no longer accepting patients. Initially posted April 11th 2019 and last edited August 19th 2022; however, 2835 other medical trials are presently searching for participants."
Answered by AI
Has anything similar been attempted before this particular experiment?
"At present, 333 studies featuring the drug pemetrexed are underway over 2570 cities and 75 nations. Genzyme, a Sanofi Company, conducted one of the earliest trials in 2007 which involved 698 patients and concluded its Phase 3 stage. Since then 345 additional clinical investigations have been completed."
Answered by AI
How many participants are included in this experiment?
"At present, this medical trial is not enrolling any new patients. It was posted on April 11th 2019 and last updated August 19th 2022. For persons seeking alternate trials, there are 2502 studies recruiting for infiltrating bladder urothelial carcinoma with glandular differentiation and 333 clinical trials using Pemetrexed that need participants."
Answered by AI
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