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Monoclonal Antibodies

Brachytherapy + Immunotherapy for Recurrent Gynecological Cancer

Phase 2

Waitlist Available

Led By Albert J Chang

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disease amenable to be treated safely with brachytherapy

Subjects with platinum-resistant or refractory, recurrent or metastatic gynecological malignancies, including ovarian, endometrial, or cervical cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is studying brachytherapy with durvalumab or tremelimumab to treat patients with gynecological malignancies that is resistant to platinum therapy (platinum-resistant), does not respond to treatment (refractory), has come back (recurrent), or has spread to other places in body (metastatic).

Who is the study for?

This trial is for women with certain gynecological cancers (like ovarian, endometrial, or cervical) that haven't responded to platinum therapy and may have spread. Participants should be in good enough health to undergo internal radiation, not pregnant, able to consent, and without serious infections like TB or hepatitis. They shouldn't have used checkpoint inhibitors before or had recent major surgery.Check my eligibility

What is being tested?

The study tests brachytherapy combined with the immune-boosting drugs Durvalumab or Tremelimumab on gynecological cancers resistant to standard treatments. It aims to see if placing radioactive material near tumors plus immunotherapy can effectively kill cancer cells and prevent growth.See study design

What are the potential side effects?

Possible side effects include typical reactions from radiation like localized pain and fatigue as well as immune-related issues such as inflammation in various organs due to Durvalumab or Tremelimumab. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

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

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My condition can be safely treated with internal radiation.

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My cancer is resistant to platinum-based treatments and has come back or spread.

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I am post-menopausal or not pregnant if pre-menopausal.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 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 (safety lead-in)

Progression free survival (PFS) (dose expansion)

Secondary outcome measures

Disease-specific survival

Duration of response (DoR)

Local control at the irradiated site

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (tremelimumab, brachytherapy)Experimental Treatment2 Interventions

Patients receive tremelimumab IV on day 1. Treatment repeats every 28 days for 2-4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo brachytherapy on day 8. Treatment repeats every 21 days for 3 fractions in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (durvalumab, brachytherapy)Experimental Treatment2 Interventions

Patients receive durvalumab IV on day 1. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo brachytherapy on day 8. Treatment repeats every 21 days for 3 fractions in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Internal Radiation Therapy

2006

Completed Phase 3

~290

Durvalumab

2017

Completed Phase 2

~3870

Tremelimumab

2017

Completed Phase 2

~3380

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,041 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,262 Previous Clinical Trials

288,594,207 Total Patients Enrolled

Albert J ChangPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

1 Previous Clinical Trials

17 Total Patients Enrolled

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04395079 — Phase 2

Malignant Female Reproductive System Neoplasm Research Study Groups: Arm I (durvalumab, brachytherapy), Arm II (tremelimumab, brachytherapy)

Malignant Female Reproductive System Neoplasm Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04395079 — Phase 2

Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04395079 — Phase 2

Frequently Asked Questions

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

Have there been any earlier explorations into the efficacy of Internal Radiation Therapy?

"Currently, 340 studies are exploring Internal Radiation Therapy with 52 trials in their final phase. While the bulk of these research endeavours are conducted out of Cordoba, Texas, there is a total 13095 sites engaging in clinical trials for this form of therapy."

Answered by AI

Is this research still actively looking for participants?

"Per clinicaltrials.gov, this medical trial is currently not recruiting individuals for participation. The study was initially advertised on August 7th 2020 and the most recent editing occurred June 17th 2022. However, there are presently 3,650 other trials actively seeking participants."

Answered by AI

In what diseases is Internal Radiation Therapy typically employed?

"Internal Radiation Therapy is typically applied to treat unresectable Stage III non-small cell lung cancer and other conditions, such as metastatic urothelial carcinoma or advance directives."

Answered by AI

How have studies evaluated the safety of Internal Radiation Therapy for patients?

"Our team assigned Internal Radiation Therapy a score of 2, as safety has been evaluated in Phase 2 trials though efficacy is yet to be definitively established."

Answered by AI

How many participants are currently receiving enrollment into the experiment?

"Currently, this medical trial is not accepting patients. It was first published on August 7th 2020 and last edited on June 17th 2022. However, if you are seeking alternative studies there are 3,310 clinical trials involving neoplasms that remain open to recruitment as well as 340 Internal Radiation Therapy related trials actively recruiting participants."

Answered by AI

Does this research offer any groundbreaking discoveries?

"Since 2007, Internal Radiation Therapy has been the focus of numerous clinical trials. A seminal study sponsored by AstraZeneca in 2007 first demonstrated its efficacy, which led to Phase 2 drug approval later that year. Currently, 340 active studies for this radiation therapy are being conducted across 58 countries and 1327 cities worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brachytherapy With Durvalumab or Tremelimumab for the Treatment of Patients With Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies

2020. "Brachytherapy With Durvalumab or Tremelimumab for the Treatment of Patients With Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04395079.

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