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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:

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I haven't taken any prostate cancer hormone treatments recently.

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I am experiencing symptoms related to spinal cord pressure.

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I have not had major surgery in the last 4 weeks.

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I cannot or will not take pills or receive treatments through an IV.

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I have started treatment for metastatic castration-resistant prostate cancer.

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I do not have any severe illnesses that are not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 21 months after the first subject is randomized.

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%

HYPERTENSION

36%

HEADACHE

36%

PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME

36%

PAIN IN EXTREMITY

32%

PROTEINURIA

32%

PAIN

27%

White Blood Cell Count Decreased

27%

ABDOMINAL PAIN

23%

PLATELET COUNT DECREASE

23%

Renal & Urinary Disorders - Other, Ketonuria

23%

HYPONATREMIA

23%

Decreased Platelet Count

23%

Platelet Count Decreased

23%

Skin Hypopigmentation

23%

HAIR COLOR CHANGE

18%

Upper Respiratory Infection

18%

HEMOGLOBIN INCREASED

18%

HYPOKALEMIA

18%

HYPOPHOSPHATEMIA

18%

Alopecia

18%

Hyperkalemia

14%

HYPERGLYCEMIA

14%

Pruritis

14%

HYPOGLYCEMIA

14%

Rash Acneiform

14%

Rash Maculopapular

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

Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified

NASAL CONGESTION

TUMOR PAIN

Papulopustular Rash

ALKALINE PHOSPHATASE INCREASED

Creatinine Increased

Back Pain

ABSOLUTE NEUTROPHIL COUNT DECREASED

LIPASE INCREASED

Paresthesia

ORAL PAIN

LYMPHOCYTE COUNT DECREASED

WEIGHT GAIN

HYPOCALCEMIA

DRY SKIN

Hypotension

URINARY URGENCY

Injury, Poisoning And Procedural Complications - Other, Ankle Injury

Injury, Poisoning And Procedural Complications- Other, Scalp Laceration

Peripheral Sensory Neuropathy

Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change

Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)

Joint Range Of Motion Decreased

Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis

Hypertension

SERUM AMYLASE INCREASED

Investigations - Other, Eosinophilia

Allergic Rhinitis

ANXIETY

Hypermagnesemia

Rash Ezcematoid

Behaviour Disturbance

Scalp Pain

Psychiatric Disorders - Other, Mood Swings

Sinus Tachycardia

Periodontal Disease

Myalgia

Tooth Infection

URINARY FREQUENCY

Conjunctivitis

Sinusitis

Syncope

Activated Partial Thromboplastin Time Prolonged

Breast Pain

Peripheral Motor Neuropathy

Scalp Lesion

Sore Throat

Tachycardia

JOINT RANGE OF MOTION DECREASED

INSOMNIA

Skin And Subcutaneous Disorders - Other, Dry Skin Patches

HEMATURIA

RASH

Gastrointestinal Disorders - Other, Buccal Cyst

Investigations - Other, International Normalized Ration Increased

Infections And Infestations - Other, Gi Viral Infection

Gastrointestinal Disorders - Other, Dental Pain

Stomach Pain

SKIN INFECTION

HYPOMAGNESEMIA

Muscle Weakness Upper Limb

Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger

Skin And Subcutaneous Tissue Disorders- Other, Erythema

Neuropathy

Infections And Infestations - Other, Covid-19

Investigations - Other, Increased Mean Corpuscular Volume

DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS

Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles

Surgical & Medical Procedures - Other, Dental Extractions

TENDONITIS

SINUS BRADYCARDIA

HYPERTHYROIDISM

Creatine Phosphokinase Increased

SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE

Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips

Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema

Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps

Muscle Weakness Lower Limb

Urine Discoloration

SPINAL CORD COMPRESSION

ANEMIA

PARONYCHIA

BRUISING

HYPOALBUMINEMIA

Ear And Labyrinth Disorders - Other, Impacted Cerumen

Ear Pain

Elevated Amylase

Facial Pain

Gastrointestinal Disorders - Other, Stomatitis

Hoarseness

Laryngitis

Leg Pain

Localized Edema

Lung Infection

Metabolism And Nutrition Disorders - Other, Decreased Oral Intake

Metabolism Other - Decreased Vitamin D

Metbolism And Nutrition Disorders - Other, Hyperchloremia

Mucositis Oral

100%

80%

60%

40%

20%

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

~2360

Atezolizumab

2016

Completed Phase 3

~5860