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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
Must not have
Patients with known brain metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am 18 years old or older.
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I agree to a biopsy or providing previous biopsy samples.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer is in the cervix, vagina, or vulva and has come back or spread.
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My cancer can be measured and is at least 1 cm in size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer that has spread to my brain.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
Overall Survival (OS)
Progression-free Survival (PFS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2016
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
562 Previous Clinical Trials
144,822 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,560 Previous Clinical Trials
569,408 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
~3 spots leftby Oct 2025
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