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Checkpoint Inhibitor

Durvalumab + Tremelimumab for Bladder Cancer

Phase < 1

Waitlist Available

Led By Jianjun Gao

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

Nonsterilized males who are sexually active with a female partner of childbearing potential must agree to use a highly effective method of contraception

Patients must have tissue resected by transurethral resection of bladder tissue (TURBT) at the MD Anderson Cancer Center

Must not have

Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment

Major surgical procedure within 28 days prior to the first dose of durvalumab and tremelimumab or still recovering from prior surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if durvalumab and tremelimumab are safe and have side effects in patients with muscle-invasive, high-risk urothelial cancer.

Who is the study for?

This trial is for patients with muscle-invasive, high-risk urothelial cancer who can't have cisplatin-based therapy. They need proof of cancer from a specific bladder tissue resection, good organ and marrow function, no prior immunotherapy, an ECOG status of 0-1, and must agree to use effective contraception if applicable. Exclusions include HIV/AIDS, recent vaccines or surgeries, pregnancy, uncontrolled illnesses, allergies to study drugs, other ongoing cancer treatments or trials (with exceptions), certain autoimmune diseases or conditions.

What is being tested?

The trial tests durvalumab and tremelimumab's safety in treating urothelial cancers that are ineligible for cisplatin before surgery. These monoclonal antibodies may boost the immune system to stop tumor growth and spread. It's a phase I pilot study focusing on side effects as well as potential efficacy.

What are the potential side effects?

Possible side effects include immune-related reactions such as inflammation in various organs which might mimic autoimmune diseases; infusion reactions during treatment administration; fatigue; increased risk of infections due to immune modulation; and potentially others not yet known.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man who can father children and will use effective birth control.

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My bladder tissue was removed at MD Anderson Cancer Center.

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I have been diagnosed with cancer in my bladder or urinary system.

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I am fully active or can carry out light work.

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I have never received immunotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently on any cancer treatments like chemotherapy or immunotherapy.

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I haven't had major surgery in the last 28 days or am still recovering from one.

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I still have side effects from previous cancer treatments.

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I have an autoimmune disease.

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I do not have any uncontrolled illnesses.

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I have not had any other cancer besides this one in the last 2 years.

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My cancer has spread beyond the bladder.

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

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I haven't had any live vaccines in the last 4 weeks.

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I am currently receiving dialysis.

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I have received an organ transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Anorexia

30%

Constipation

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

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 (tremelimumab, durvalumab)Experimental Treatment3 Interventions

Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1 of weeks 1 and 4. Beginning 4-6 weeks after the last infusion, patients undergo cystectomy with pelvic lymph node dissection surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Tremelimumab

2017

Completed Phase 2

~3070