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Monoclonal Antibodies

Atezolizumab + Chemoradiotherapy for Cervical Cancer

Phase 1

Waitlist Available

Led By Jyoti S Mayadev

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Creatinine clearance =< 1.5 mg/dL to receive weekly cisplatin

Patient does not have a known allergy to cisplatin or compounds of similar biologic composition

Must not have

Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab

History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well atezolizumab, given before and/or with standard of care chemoradiotherapy, works in immune system activation in patients with cervical cancer.

Who is the study for?

This trial is for patients with advanced cervical cancer (stages IB2, II, IIIB, or IVA) that has spread to lymph nodes. Participants must have adequate blood counts and organ function, no severe allergies to cisplatin or immunotherapy drugs like atezolizumab, not be breastfeeding, and able to consent. HIV-positive patients can join if well-managed. Exclusions include prior pelvic radiation or systemic anticancer therapy within 3 years and certain health conditions.

What is being tested?

The study tests the effectiveness of atezolizumab when given before and/or alongside standard chemoradiotherapy in activating the immune system against cervical cancer. Atezolizumab is a monoclonal antibody designed to help the body's immune system detect and fight tumor cells.

What are the potential side effects?

Atezolizumab may cause side effects such as inflammation in organs like lungs (pneumonitis), infusion reactions during administration, fatigue, liver issues indicated by enzyme changes in blood tests, potential infections due to immune suppression caused by medication.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function is good enough for a specific chemotherapy.

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I am not allergic to cisplatin or similar drugs.

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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 cervical cancer is newly diagnosed and advanced.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

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I have a history of lung scarring or inflammation.

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I haven't had major surgery in the last 28 days and don't expect to need one during the study.

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I do not have any uncontrolled illnesses.

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I have not had severe infections in the last 4 weeks.

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I have a brain tumor or cancer that has spread to my brain.

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I have had radiation therapy in the pelvis or abdomen, or for this or any cancer before.

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I have a significant liver condition, such as hepatitis or cirrhosis.

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I have not had signs of infection in the last 2 weeks.

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I have serious heart or brain blood vessel problems.

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I had a complete hysterectomy and my pelvic lymph nodes were cancerous.

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My cancer has spread to lymph nodes above my waist.

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I am on bisphosphonate therapy for high calcium levels.

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I need a RANKL inhibitor like denosumab and can't stop it for atezolizumab treatment.

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I haven't taken any immune-weakening medications in the last 2 weeks.

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I have active tuberculosis.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Immune Response

Secondary study objectives

Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5

Disease-free Survival (DFS) at 2 Years

Percentage of Participants With Dose Limiting Toxicities

+4 more

Other study objectives

Biomarker levels in blood and tissue

Response assessment

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (atezolizumab, standard cisplatin and radiation therapy)Experimental Treatment4 Interventions

Patients receive atezolizumab IV over 30-60 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care cisplatin chemotherapy, radiation therapy, and image guided brachytherapy as in Arm A.

Group II: Arm A (atezolizumab, standard cisplatin and radiation therapy)Experimental Treatment4 Interventions

Patients receive atezolizumab IV over 30-60 minutes on days -21, 0, and 21 in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care cisplatin chemotherapy IV over 90 minutes on days 0, 7, 14, 21, 28, and 35. Beginning on day 0, patients also receive standard of care radiation therapy once daily (Monday-Friday) for a total of 25 fractions with image guided brachytherapy beginning in week 4, 5, or at the end of radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Brachytherapy

2007

Completed Phase 3

~2140