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Checkpoint Inhibitor
Atezolizumab + Cabozantinib for Kidney Cancer (CONTACT-03 Trial)
Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary, chromophobe, and unclassified only) RCC. RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation.
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to the first occurrence of disease progression according to recist v1.1 (up to 2 years 5 months).
Awards & highlights
CONTACT-03 Trial Summary
This trial is testing a new combination cancer treatment to see if it is more effective and has fewer side effects than the current standard of care.
Who is the study for?
This trial is for adults with advanced renal cell carcinoma who've seen their cancer grow despite previous immune checkpoint inhibitor therapy. They must have a certain level of physical health, no recent other cancer treatments or surgeries, and agree to contraception if applicable. Those with uncontrolled blood pressure, significant heart disease, active infections or hepatitis are excluded.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of atezolizumab combined with cabozantinib versus cabozantinib alone in patients whose kidney cancer has progressed after treatment with drugs that boost the immune system. It's an open-label Phase III trial where participants are randomly assigned to one of the two treatment groups.See study design
What are the potential side effects?
Potential side effects include fatigue, high blood pressure, diarrhea, liver enzyme elevation, mouth sores, hand-foot syndrome (redness and pain on palms or soles), decreased appetite and weight loss. Some may experience more serious issues like severe infections or allergic reactions.
CONTACT-03 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer is advanced or has spread, and it's a specific type (clear cell, papillary, chromophobe, or unclassified).
Select...
I agree to not have sex or will use a condom, and I won't donate sperm.
Select...
I am mostly able to care for myself.
CONTACT-03 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to the first occurrence of disease progression according to recist v1.1 (up to 2 years 5 months).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to the first occurrence of disease progression according to recist v1.1 (up to 2 years 5 months).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression Free Survival (PFS) as Assessed by an Independent Review Facility (IRF) (IRF-PFS) According to RECIST v1.1
Secondary outcome measures
Independent Review Facility (IRF)-Assessed Duration of Response (DOR) (IRF-DOR) According to RECIST v1.1
Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1
Investigator-assessed Duration of Response (DOR) (INV-DOR) According to RECIST v1.1
+2 moreSide 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
CONTACT-03 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Atezo+CaboExperimental Treatment2 Interventions
Participants will receive atezolizumab every 3 weeks on Day 1 of each 21-day cycle (1 cycle=21 days) plus oral tablets of cabozantinib every day.
Group II: CabozantinibActive Control1 Intervention
Participants will receive cabozantinib every day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Cabozantinib
2020
Completed Phase 2
~1080
Find a Location
Who is running the clinical trial?
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,029 Total Patients Enrolled
ChugaiUNKNOWN
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,532 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had serious heart problems in the last 3 months.I have been treated with an mTOR inhibitor before.I have brain metastases that are untreated or getting worse.My kidney cancer is advanced or has spread, and it's a specific type (clear cell, papillary, chromophobe, or unclassified).I have not had radiotherapy for kidney cancer in the last 14 days.I have recovered from previous cancer treatment side effects, except for moderate hair loss.My high blood pressure is not controlled by medication.I can provide both old and recent tumor samples for the study.I have had cancer spread to the lining of my brain and spinal cord.I haven't had cancer treatment in the last 14 days.I have had more than one immune therapy for advanced cancer.I have taken cabozantinib before.I have had more than two treatments for my advanced cancer.I agree to not have sex or will use a condom, and I won't donate sperm.I have active tuberculosis.I haven't had cancer other than kidney cancer in the last 5 years.I have high calcium levels in my blood that are not under control or cause symptoms.I haven't had major blood vessel problems or surgeries in the last 6 months.You have had a heart test (ECG) that showed a significant problem, according to the doctor's opinion.I am currently taking blood thinners like warfarin or clopidogrel.My blood and organs are functioning well.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.My kidney cancer worsened after or during treatment with specific immune therapy.I have not had a severe infection or been hospitalized for one in the last 4 weeks.I have untreated, symptomatic underactive thyroid.I have a history of congenital QT syndrome.You have a disease that can be measured using a specific set of guidelines.A score based on certain factors that will be used to assess your risk.You need to have a negative test for hepatitis C virus (HCV) antibodies. If the test is positive, you need to have a negative HCV RNA test.I am mostly able to care for myself.You need to have a negative HIV test when you are screened for the trial.You tested negative for hepatitis B before joining the study.I frequently need procedures to remove excess fluid from my chest or abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Atezo+Cabo
- Group 2: Cabozantinib
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Is this a new clinical trial?
"Atezolizumab has been researched for over a decade, with the first study taking place in 2008. Sponsored by Hoffmann-La Roche, this initial trial had 720 participants. After successful completion, Atezolizumab was approved for Phase 2 drug trials. As of now, there are 458 active clinical trials located in 75 countries and 1957 cities worldwide."
Answered by AI
What are the possible side effects of Atezolizumab?
"Atezolizumab is safe according to our Power's 1-3 safety scale because this is a Phase 3 trial with supporting efficacy data and rounds of safety data."
Answered by AI
Atezolizumab is often used to treat patients with what specific condition?
"Atezolizumab is a medication used to treat small cell lung cancer, however it can also be effect for patients that have been previously treated with anti-vegf or have high risk malignant neoplasms."
Answered by AI
Are new participants being sought for this trial?
"This specific clinical trial is not looking for new participants, however there are 3120 other trials with open recruitment. The original posting date was July 28th, 2020 and the most recent update was on October 26th, 2022."
Answered by AI
What is the target sample size for this research project?
"Unfortunately, this study is not admitting new patients at the present time. The clinical trial was posted on 7/28/2020 and was most recently edited on 10/26/2022; however, there are 2662 other trials for carcinoma, renal cell actively recruiting patients and 458 studies using Atezolizumab presently enrolling participants."
Answered by AI
What does the current research say about Atezolizumab's effectiveness?
"Atezolizumab was first investigated in 2008 by Can Care Assoc Med Group Inc; Beach Cities Offices. There have been 134 completed studies since then and 458 are currently ongoing. A large proportion of these are taking place in Tucson, Arizona."
Answered by AI
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