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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My kidney function is good enough for a specific chemotherapy.
Select...
I am not allergic to cisplatin or similar drugs.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My cervical cancer is newly diagnosed and advanced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immune Response
Secondary outcome measures
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 moreOther outcome measures
Biomarker levels in blood and tissue
Response assessment
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
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
~1940
Radiation Therapy
2017
Completed Phase 3
~7250
Atezolizumab
2017
Completed Phase 3
~5860
Brachytherapy
2007
Completed Phase 3
~2100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,601 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,812 Total Patients Enrolled
Jyoti S MayadevPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
34 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 4 weeks and do not plan to during the study.My hemoglobin level is at least 8 g/dL.I have a history of lung scarring or inflammation.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I do not have any uncontrolled illnesses.I have not had severe infections in the last 4 weeks.I have had cancer treatment within the last 3 years.My kidney function is good enough for a specific chemotherapy.I am not allergic to cisplatin or similar drugs.I have a brain tumor or cancer that has spread to my brain.I have had radiation therapy in the pelvis or abdomen, or for this or any cancer before.I have received IV antibiotics within the last 2 weeks.I have a significant liver condition, such as hepatitis or cirrhosis.I have not had signs of infection in the last 2 weeks.I have serious heart or brain blood vessel problems.I had a complete hysterectomy and my pelvic lymph nodes were cancerous.I can take care of myself but might not be able to do heavy physical work.My cancer has spread to lymph nodes above my waist.My cervical cancer is newly diagnosed and advanced.I am on bisphosphonate therapy for high calcium levels.I need a RANKL inhibitor like denosumab and can't stop it for atezolizumab treatment.I haven't taken any immune-weakening medications in the last 2 weeks.I have active tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (atezolizumab, standard cisplatin and radiation therapy)
- Group 2: Arm A (atezolizumab, standard cisplatin and radiation therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what type of medical cases is Atezolizumab applied?
"Atezolizumab is typically utilized to treat pharmacotherapy, as well as more severe illnesses such as advanced testicular cancer, small cell lung cancer (SCLC), and malignant neoplasms."
Answered by AI
What potential risks do patients face when receiving Atezolizumab treatments?
"Due to limited clinical data regarding efficacy and safety of Atezolizumab, our team at Power have assigned it a score of 1."
Answered by AI
What other experiments have been done to assess the efficacy of Atezolizumab?
"The earliest research on Atezolizumab was conducted in 1997 by the City of Hope Comprehensive Cancer Center. Since then, 1151 studies have been completed and 1064 current trials are underway; a significant portion of these clinical trials are being held at Iowa City, Iowa."
Answered by AI
Is the enrollment period for this research ongoing?
"Unfortunately, this clinical trial is no longer accepting new candidates. The study was first launched in October 2018 and most recently updated at the end of November 20202. Nonetheless, 2754 trials are currently recruiting patients with stage ib2 cervical cancer ajcc v8 while 1064 studies require participants for Atezolizumab research."
Answered by AI
How many locations are currently administering this experiment?
"The trial is being administered through 16 medical centres in Iowa City, Augusta, Columbus and other localities. To limit the distance traveled for treatments it's best to look into clinics located nearby your residence."
Answered by AI
How many participants are being welcomed into this research endeavor?
"This trial has concluded its recruitment process. The research was initially posted on October 26th 2018 and most recently updated on November 26th 2022. If you are interested in other clinical studies, there are presently 2754 trials seeking participants with stage ib2 cervical cancer (AJCC v8) and 1064 involving Atezolizumab that remain active."
Answered by AI
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