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Checkpoint Inhibitor

Cabozantinib + Atezolizumab for Prostate Cancer (CONTACT-02 Trial)

Phase 3
Waitlist Available
Research Sponsored by Exelixis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment defined by at least one of the following: measurable visceral disease (eg, adrenal, kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic adenopathy (ie, adenopathy above the aortic bifurcation)
ECOG performance status of 0 or 1
Must not have
Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2 weeks before randomization
Symptomatic or impending spinal cord compression or cauda equina syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 21 months after the first subject is randomized.
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the safety and efficacy of cabozantinib in combination with atezolizumab versus a second novel hormonal therapy in men with mCRPC.

Who is the study for?
Men with advanced prostate cancer that has resisted castration and have already tried one hormonal therapy can join. They must be adults with good organ function, able to follow the study plan, and not have other active cancers or severe illnesses. Men who've had major surgery recently or those on certain medications are excluded.
What is being tested?
The trial is testing Cabozantinib combined with Atezolizumab against a second novel hormonal therapy (NHT) in men whose prostate cancer has spread despite castration. It's a Phase 3 study where participants are randomly assigned to either treatment group.
What are the potential side effects?
Possible side effects include high blood pressure, tiredness, liver issues, mouth sores, hand-foot syndrome for Cabozantinib; while Atezolizumab may cause immune-related reactions like rash or inflammation of organs such as lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have cancer that has spread outside my pelvis and can be measured.
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I am fully active or can carry out light work.
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I have had one hormone therapy for my advanced prostate cancer.
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I am legally considered an adult in my country and am at least 18 years old.
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I have undergone castration, and my testosterone levels are low.
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I am a man diagnosed with prostate cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't taken any prostate cancer hormone treatments recently.
Select...
I am experiencing symptoms related to spinal cord pressure.
Select...
I have not had major surgery in the last 4 weeks.
Select...
I cannot or will not take pills or receive treatments through an IV.
Select...
I have started treatment for metastatic castration-resistant prostate cancer.
Select...
I do not have any severe illnesses that are not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 21 months after the first subject is randomized.
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 21 months after the first subject is randomized. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of Overall Survival (OS)
Duration of Progression Free Survival per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Secondary study objectives
Objective response rate (ORR)

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
NAUSEA
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
HAIR COLOR CHANGE
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Rash Acneiform
14%
Pruritis
14%
Rash Maculopapular
14%
HYPOGLYCEMIA
14%
HYPERGLYCEMIA
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
CONSTIPATION
14%
Fever
9%
TUMOR PAIN
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
Paresthesia
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Muscle Weakness Lower Limb
5%
Allergic Rhinitis
5%
Hypotension
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Investigations - Other, Eosinophilia
5%
Sore Throat
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Scalp Pain
5%
Scalp Lesion
5%
Neuropathy
5%
Psychiatric Disorders - Other, Mood Swings
5%
URINARY URGENCY
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Myalgia
5%
Tooth Infection
5%
RASH
5%
Peripheral Motor Neuropathy
5%
Tachycardia
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Sinusitis
5%
Syncope
5%
Activated Partial Thromboplastin Time Prolonged
5%
Breast Pain
5%
JOINT RANGE OF MOTION DECREASED
5%
INSOMNIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
HEMATURIA
5%
Investigations - Other, International Normalized Ration Increased
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Joint Range Of Motion Decreased
5%
Behaviour Disturbance
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Stomach Pain
5%
TENDONITIS
5%
SKIN INFECTION
5%
HYPOMAGNESEMIA
5%
Muscle Weakness Upper Limb
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Infections And Infestations - Other, Covid-19
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A

Awards & Highlights

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.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental ArmExperimental Treatment2 Interventions
Subjects with mCRPC will receive cabozantinib 40mg oral, qd + atezolizumab 1200mg infusion, q3w
Group II: Control ArmActive Control3 Interventions
Subjects with mCRPC will receive active comparator of EITHER abiraterone 1000mg oral, qd + prednisone 5 mg oral, bid; OR enzalutamide 160mg oral, qd as designated by the Investigator prior to randomization
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1760
Atezolizumab
2016
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor
120 Previous Clinical Trials
19,555 Total Patients Enrolled
TakedaIndustry Sponsor
1,238 Previous Clinical Trials
4,148,592 Total Patients Enrolled
Roche-GenentechIndustry Sponsor
26 Previous Clinical Trials
3,216 Total Patients Enrolled

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