← Back to Search

Checkpoint Inhibitor

SBRT + Atezolizumab for Cervical Cancer

Phase 2

Recruiting

Led By Kamran Ahmed, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

At least 18 years of age

Consent to biopsy of metastatic site or consent to retrieval of archival tissue

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial will compare atezolizumab+SBRT to atezolizumab alone to see if the addition of SBRT improves ORR in cervical cancer patients.

Who is the study for?

This trial is for adults with recurrent, persistent, or metastatic cervical cancer who are in good enough health to undergo treatment (ECOG ≤ 2 or Karnofsky ≥ 60). They must have measurable disease and at least two distinct lesions. Those with a history of certain other cancers within the last two years, active autoimmune diseases, immune deficiencies, or recent systemic immunosuppressive treatments cannot participate.Check my eligibility

What is being tested?

The study aims to determine if combining Atezolizumab (an immunotherapy drug) with Stereotactic Body Radiation Therapy (SBRT), which is a precise high-dose radiation therapy, can improve response rates in patients compared to using Atezolizumab alone for treating cervical cancer.See study design

What are the potential side effects?

Atezolizumab may cause fatigue, nausea, infections due to weakened immune system responses and potential inflammation of organs. SBRT might result in localized skin reactions and fatigue as well. The combination's side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

I agree to a biopsy or providing previous biopsy samples.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My cancer is in the cervix, vagina, or vulva and has come back or spread.

Select...

My cancer can be measured and is at least 1 cm in size.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR)

Secondary outcome measures

Overall Survival (OS)

Progression-free Survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combination TherapyExperimental Treatment2 Interventions

Stereotactic body radiation therapy (SBRT) followed by atezolizumab, 1 week later.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,466 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,540 Previous Clinical Trials

567,903 Total Patients Enrolled

Kamran Ahmed, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03614949 — Phase 2

Cervical Cancer Research Study Groups: Combination Therapy

Cervical Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03614949 — Phase 2

Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03614949 — Phase 2

Frequently Asked Questions

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

What maladies is Atezolizumab typically deployed to alleviate?

"Atezolizumab is a viable option for those suffering from small cell lung cancer, as well as postoperative malignant neoplasms and non-small cell lung carcinoma."

Answered by AI

Is there still an opportunity to join this medical research study?

"According to the information provided by clinicaltrials.gov, this research project is still open for enrolment. The initial posting of the trial has been dated back to January 29th 2019 with a recent update on November 10th 2022."

Answered by AI

How many participants are currently partaking in this research endeavor?

"Affirmative, clinicaltrials.gov notes that this research trial is actively seeking volunteers. It was initially published on January 29th 2019 and most recently updated November 10th 2022. 26 individuals are sought from 2 different sites of study."

Answered by AI

Is this a pioneering investigation in its field?

"Since the first trial led by Hoffmann-La Roche in 2008, Atezolizumab has been studied extensively. Following a successful Phase 1 study involving 720 patients, it was approved for further trials and is now being tested across 1646 locations worldwide as part of 351 live studies conducted within 74 countries."

Answered by AI

What potential hazards have been associated with Atezolizumab treatments?

"Because there is some data indicating Atezolizumab's safety but no evidence of efficacy, our team at Power assigned it a score of 2 on the 1 to 3 scale."

Answered by AI

To what extent have other researchers investigated the effects of Atezolizumab?

"Atezolizumab was initially trialled in 2008 by the SCRI Tennessee Oncology Chattanooga. Since then, 80 studies have been concluded, with 351 active trials in progress. Notably, many of these are being conducted at Hilliard Ohio."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SBRT and Atezolizumab in the Management of Recurrent, Persistent, or Metastatic Cervical Cancer

2019. "SBRT and Atezolizumab in the Management of Recurrent, Persistent, or Metastatic Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03614949.

All > Sbrt > Cervical Cancer