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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.

Must not have

Major surgical procedure (as defined by the PI or co-PIs within 28 days prior to the first dose of therapy) or still recovering from prior surgery.

Known or suspected autoimmune disease. Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener's granulomatosis) are excluded from this study.

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

No Placebo-Only Group

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.

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.

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 below

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My kidney function is normal or nearly normal.

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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:

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I have not had major surgery or am fully recovered if I did within the last 28 days.

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I do not have autoimmune diseases like Crohn's, lupus, or rheumatoid arthritis.

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I have had an organ or stem-cell transplant in the past.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I have been cancer-free for at least 2 years, except for certain skin, prostate cancers, or in situ carcinoma.

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I do not have any severe ongoing illnesses like heart problems or lung diseases.

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I have tested positive for HIV/AIDS.

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I am currently receiving dialysis.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate

Secondary study objectives

Progression free survival

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Dyspnoea

Cerebral infarction

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

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 (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

2017

Completed Phase 2

~2440

Pemetrexed

2014

Completed Phase 3

~5550