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Monoclonal Antibodies

Treatment (tremelimumab, durvalumab, SABR) for Cervical Cancer

Q: What do tremelimumab, durvalumab, and SABR typically serve as treatments for?

<p>Patients afflicted by advanced non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, previously untreated urothelial carcinoma of the metastatic ureter can be given Treatment (tremelimumab, durvalumab, SABR).</p>

Phase 1

Waitlist Available

Led By Lilie L Lin

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing a combination of two immunotherapies and radiation therapy to see if it is more effective than just radiation therapy for treating cervical, vaginal, and vulvar cancers that have returned or spread.

Eligible Conditions

Cervical Cancer
Cervical Carcinoma
Vaginal Cancer
Cervical Adenocarcinoma
Vulvar Cancer
Vulvar Squamous Cell Carcinoma
Vaginal Adenocarcinoma
Vaginal Carcinoma
Vulvar Adenocarcinoma

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 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03

Secondary outcome measures

Overall Survival

Progression-Free Survival

Response to treatment by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune-related response criteria

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (tremelimumab, durvalumab, SABR)Experimental Treatment4 Interventions

Participants receive tremelimumab IV over 1 hour followed by durvalumab IV over 1 hour on day 1 of each cycle. Participants also undergo SABR over 30-45 minutes on days 8, 10, and 12 of cycle 1. Treatment with tremelimumab repeats every 4 weeks for up to 4 cycles, and treatment with durvalumab repeats every 4 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiosurgery

2016

Completed Phase 2

~460

Tremelimumab

Not yet FDA approved

Durvalumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,761 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,133 Total Patients Enrolled

Lilie L LinPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

652 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA sanctioned tremelimumab, durvalumab, and SABR as treatments?

"Our assessment at Power gave Treatment (tremelimumab, durvalumab, SABR) a score of 1 due to the limited data available for its safety and efficacy. This is in line with it being a Phase 1 trial."

Answered by AI

Is there an ongoing enrollment period for this experiment?

"Clinicaltrials.gov confirms that this medical study, which was initially posted on July 18th 2018 and most recently edited June 19th 2023, is no longer actively recruiting patients. However, there are still 4586 other clinical trials looking for participants presently."

Answered by AI

What is the total sample size of this investigation?

"At this time, no further applicants are being sought for the trial. This research was first published on July 18th 2018 and last updated June 19th 2023; however, there are a plethora of other clinical studies actively recruiting individuals with vaginal cancer (4306) or seeking participants to test tremeleimumab, durvalumab, or SABR treatments (280)."

Answered by AI

Could you summarize any other investigations that have been conducted with tremelimumab, durvalumab, and SABR?

"Currently, there are 280 ongoing clinical trials examining the potential of tremelimumab, durvalumab and SABR. Of those studies, 44 have progressed to Phase 3. While most such experiments are conducted in Seoul or Tennessee, there are 11 738 other trial locations hosting research on these treatments."

Answered by AI

What do tremelimumab, durvalumab, and SABR typically serve as treatments for?

"Patients afflicted by advanced non-small cell lung cancer, previously untreated urothelial carcinoma of the metastatic ureter can be given Treatment (tremelimumab, durvalumab, SABR)."

Answered by AI

Is this a pioneer endeavor or has it been attempted before?

"Since 2007, AstraZeneca has sponsored research into the efficacy of tremeilimumab, durvalumab and SABR. The first study included 37 participants and ultimately led to Phase 2 drug approval for these treatments. In the present day, 280 active trials are being conducted across 1323 cities in 58 countries concerning this treatment regimen."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy, Tremelimumab and Durvalumab in Treating Participants With Recurrent or Metastatic Cervical, Vaginal, or Vulvar Cancers

2018. "Stereotactic Body Radiation Therapy, Tremelimumab and Durvalumab in Treating Participants With Recurrent or Metastatic Cervical, Vaginal, or Vulvar Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03452332.