54 Participants Needed

Durvalumab + Tremelimumab for Bladder Cancer

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This pilot phase I trial studies the side effects of durvalumab and tremelimumab in treating patients with muscle-invasive, high-risk urothelial cancer that cannot be treated with cisplatin-based therapy before surgery. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Non-cancer-related medications like insulin for diabetes are allowed.

Is the combination of Durvalumab and Tremelimumab generally safe for humans?

The combination of Durvalumab and Tremelimumab has been studied in various cancers and shows a tolerable safety profile, though it may lead to more severe side effects like reduced appetite and diarrhea compared to Durvalumab alone.12345

What makes the drug combination of Durvalumab and Tremelimumab unique for bladder cancer treatment?

The combination of Durvalumab and Tremelimumab is unique because it uses two different monoclonal antibodies to enhance the immune system's ability to fight cancer: Durvalumab blocks PD-L1, and Tremelimumab blocks CTLA-4, both of which help boost T-cell responses against cancer cells. This approach is particularly novel for patients with bladder cancer who have limited options after failing platinum-based chemotherapy.23456

What data supports the effectiveness of the drug combination Durvalumab and Tremelimumab for bladder cancer?

Durvalumab has been approved for treating advanced bladder cancer after chemotherapy, showing it can help the immune system fight cancer. Tremelimumab, when combined with Durvalumab, has been approved for other cancers like liver and lung cancer, suggesting potential effectiveness in similar conditions.23678

Who Is on the Research Team?

JG

Jianjun Gao

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I use effective birth control because I can still have children.
I am a man who can father children and will use effective birth control.
I have a mild or well-controlled autoimmune condition.
See 7 more

Exclusion Criteria

I am not currently on any cancer treatments like chemotherapy or immunotherapy.
I haven't had major surgery in the last 28 days or am still recovering from one.
You have received any experimental cancer treatment within the 28 days before starting durvalumab and tremelimumab.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive tremelimumab and durvalumab intravenously on day 1 of weeks 1 and 4

4 weeks
2 visits (in-person)

Surgery

Patients undergo cystectomy with pelvic lymph node dissection surgery 4-6 weeks after the last infusion

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
1 visit at 90 days, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Durvalumab
  • Therapeutic Conventional Surgery
  • Tremelimumab
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (tremelimumab, durvalumab)Experimental Treatment3 Interventions

Durvalumab is already approved in European Union, United States, Japan for the following indications:

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Approved in European Union as Imfinzi for:
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Approved in United States as Imfinzi for:
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Approved in Japan as Imfinzi for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Durvalumab is an FDA-approved monoclonal antibody that enhances T-cell responses against cancer by blocking the PD-L1 pathway, specifically for patients with advanced urothelial carcinoma who have progressed after platinum-based chemotherapy.
The drug is currently being tested in phase III trials for various cancers, including lung and head and neck cancers, indicating its potential broad application in oncology beyond urothelial carcinoma.
Durvalumab: First Global Approval.Syed, YY.[2022]
Tremelimumab, a CTLA-4 blocking antibody, was approved in the USA in October 2022 for treating unresectable hepatocellular carcinoma (uHCC) in combination with durvalumab, marking a significant advancement in cancer therapy.
In November 2022, tremelimumab was also approved for metastatic non-small cell lung cancer (mNSCLC) when combined with durvalumab and platinum-based chemotherapy, indicating its broad potential in treating various malignant tumors.
Tremelimumab: First Approval.Keam, SJ.[2023]
In the phase 3 MYSTIC study involving 488 treatment-naïve patients with metastatic non-small-cell lung cancer, durvalumab alone or in combination with tremelimumab showed significant improvements in patient-reported outcomes (PROs) compared to chemotherapy, particularly in reducing fatigue and appetite loss.
Patients receiving durvalumab-containing treatments experienced a longer time to deterioration in quality of life and physical functioning, indicating that these treatments may help maintain better overall well-being without negatively impacting quality of life.
Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC).Garon, EB., Cho, BC., Reinmuth, N., et al.[2022]

Citations

Durvalumab: First Global Approval. [2022]
Efficacy and Tolerability of Tremelimumab in Locally Advanced or Metastatic Urothelial Carcinoma Patients Who Have Failed First-Line Platinum-Based Chemotherapy. [2023]
Tremelimumab: First Approval. [2023]
Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC). [2022]
Patient-reported outcomes with durvalumab, with or without tremelimumab, plus chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (POSEIDON). [2023]
Adverse Events and Tolerability of Combined Durvalumab and Tremelimumab versus Durvalumab Alone in Solid Cancers: A Systematic Review and Meta-Analysis. [2023]
Phase I Study of Tremelimumab Monotherapy or in Combination With Durvalumab in Japanese Patients With Advanced Solid Tumors or Malignant Mesothelioma. [2022]
Durvalumab and tremelimumab combination therapy versus durvalumab or tremelimumab monotherapy for patients with solid tumors: A systematic review and meta-analysis. [2022]
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