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Checkpoint Inhibitor

Durvalumab + Tremelimumab for Bladder Cancer

Q: Are there any existing research papers that document the effects of Durvalumab?

Presently, there are 340 clinical trials in existence that involve Durvalumab. Out of these studies, 51 have progressed to Phase 3 and most are located within Taipei or <a href="https://www.withpower.com/clinical-trials/tennessee">Tennessee</a>; however, the medication is being trialed at 13054 different sites around the world.

Q: What disorders does Durvalumab commonly aim to alleviate?

Durvalumab is used to treat patients with unresectable stage III non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, individuals that have not undergone treatment before and those suffering from metastatic urothelial carcinoma.

Q: Is this the inaugural research of its kind?

Presently, 340 active clinical trials are being conducted with Durvalumab across 58 nations and 1327 cities. Initially launched in 2007 by AstraZeneca, the drug was tested on 37 patients who completed Phase 2 of approval. Subsequently, a further 154 studies were carried out over time.

Q: Is it still feasible for individuals to join the trial?

This research trial is not currently seeking participants; it was originally posted on March 7th 2017 and the latest update was made October 31st 2022. However, if you are looking for other studies to participate in, there are 2,647 ongoing trials involving hydronephrosis and 340 studies concerning Durvalumab that require enrolment.

Q: What is the scope of participants involved in this research?

Unfortunately, recruitment for this trial has been concluded and the listing was last modified on October 31st 2022. If you are looking to take part in other medical studies related to hydronephrosis, there are currently 2647 clinical trials accepting new patients. Durvalumab is being tested by 340 separate investigations that require participants.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

My bladder tissue was removed at MD Anderson Cancer Center.

Select...

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

Select...

I am fully active or can carry out light work.

Select...

I have never received immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

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 determined by extreme toxicity

Secondary outcome measures

Change in immune and molecular responses in peripheral blood and tumor tissues

Pathologic down-staging to T0 disease

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%

Constipation

30%

Anorexia

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Back pain

15%

Cough

15%

Abdominal Pain

15%

Weight gain

15%

Increased Urinary Frequency

13%

Arthralgia

10%

Anxiety

10%

Bladder infection

10%

Dizziness

10%

Nasal congestion

10%

Vaginal discharge

Edema limbs

Fever

Anal pain

Dry skin

Colitis

Thromboembolic event

Dry mouth

Flatulence

Headache

Hot flashes

Myalgia

Urinary tract pain

Urinary frequency

Small intestinal obstruction

Anemia

Ascites

Confusion

Pneumonitis

Sinus bradycardia

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Memory impairment

Vaginal hemorrhage

Hypomagnesemia

Upper respiratory infection

Mucositis oral

Rash acneiform

Urinary urgency

Gastroesophageal reflux disease

Lymphedema

Rectal hemorrhage

Colonic perforation

Generalized muscle weakness

Hyperkalemia

Lethargy

Myocarditis

Fall

Skin infection

Hypothyroidism

Muscle weakness left-sided

Alanine aminotransferase increased

Hyperglycemia

Pleural effusion

Creatinine increased

Rectal pain

Aspartate aminotransferase increased

Dysarthria

Myositis

CPK increased

Pain in extremity

Peripheral sensory neuropathy

Alkaline phosphatase increased

Blood bilirubin increased

Left ventricular systolic dysfunction

Weight Loss

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

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

~3870

Tremelimumab

2017

Completed Phase 2

~3380

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,976 Previous Clinical Trials

1,789,454 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,317 Total Patients Enrolled

Jianjun GaoPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

7 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any existing research papers that document the effects of Durvalumab?

"Presently, there are 340 clinical trials in existence that involve Durvalumab. Out of these studies, 51 have progressed to Phase 3 and most are located within Taipei or Tennessee; however, the medication is being trialed at 13054 different sites around the world."

Answered by AI

What disorders does Durvalumab commonly aim to alleviate?

"Durvalumab is used to treat patients with unresectable stage III non-small cell lung cancer, individuals that have not undergone treatment before and those suffering from metastatic urothelial carcinoma."

Answered by AI

Is this the inaugural research of its kind?

"Presently, 340 active clinical trials are being conducted with Durvalumab across 58 nations and 1327 cities. Initially launched in 2007 by AstraZeneca, the drug was tested on 37 patients who completed Phase 2 of approval. Subsequently, a further 154 studies were carried out over time."

Answered by AI

Is it still feasible for individuals to join the trial?

"This research trial is not currently seeking participants; it was originally posted on March 7th 2017 and the latest update was made October 31st 2022. However, if you are looking for other studies to participate in, there are 2,647 ongoing trials involving hydronephrosis and 340 studies concerning Durvalumab that require enrolment."

Answered by AI

What is the scope of participants involved in this research?

"Unfortunately, recruitment for this trial has been concluded and the listing was last modified on October 31st 2022. If you are looking to take part in other medical studies related to hydronephrosis, there are currently 2647 clinical trials accepting new patients. Durvalumab is being tested by 340 separate investigations that require participants."

Answered by AI

Recent research and studies

Nature MedicineJournal

Neoadjuvant PD-L1 Plus CTLA-4 Blockade in Patients with Cisplatin-ineligible Operable High-risk Urothelial Carcinoma

Gao, Jianjun, Neema Navai, Omar Alhalabi, Arlene Siefker-Radtke, Matthew T. Campbell, Rebecca Slack Tidwell, Charles C. Guo, et al.. 2020. “Neoadjuvant PD-L1 Plus CTLA-4 Blockade in Patients with Cisplatin-ineligible Operable High-risk Urothelial Carcinoma”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-020-1086-y.

clinicaltrials.govStudy

Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery

2017. "Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02812420.

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