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PD-L1 Inhibitor

Cabozantinib + Atezolizumab for Advanced Cancers

Q: What are the primary conditions that cabozantinib is used to treat?

<p>Cabozantinib can be used to treat <a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a> (<a href="https://www.withpower.com/clinical-trials/sclc">SCLC</a>), as well as conditions such as previously treated with anti-VEGF, malignant neoplasms, and high risk patients.</p>

Phase 1 & 2

Waitlist Available

Research Sponsored by Exelixis

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Age eighteen years or older on the day of consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 41 months

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new cancer drug when used in combination with another cancer drug. The new drug is being tested on people with different types of cancer, including bladder, kidney, prostate, and breast cancer.

Who is the study for?

Adults with various advanced or recurrent solid tumors, including specific cancers like bladder, kidney, prostate, lung, breast (triple negative), ovarian, endometrial, liver, stomach/esophageal junction/lower esophagus cancer. Participants must have measurable disease and be in good physical condition (ECOG 0-1). They should not be pregnant and agree to use contraception. Prior treatments are allowed except for cabozantinib or certain immune therapies unless specified.Check my eligibility

What is being tested?

The trial is testing the combination of two drugs: Cabozantinib and Atezolizumab in patients with multiple types of advanced cancers. It has two stages; first determining the best dose of Cabozantinib to combine with standard Atezolizumab doses and then expanding to more patients to assess safety and effectiveness.See study design

What are the potential side effects?

Possible side effects include fatigue, high blood pressure from Cabozantinib; while Atezolizumab may cause immune-related reactions such as inflammation in organs like lungs or intestines. Both can affect liver function tests and potentially lead to bleeding.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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I am 18 years old or older.

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I have kidney cancer, and it may or may not have been treated before.

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I am not pregnant and can become pregnant.

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My cancer is confirmed, cannot be removed by surgery, and has spread or come back.

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My cancer is advanced and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 41 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 41 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 41 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Escalation: MTD/Recommended Dose

Dose Expansion: ORR

Secondary outcome measures

Incidence and severity of nonserious AEs and SAEs (Safety)

Side effects data

From 2015 Phase 3 trial • 1028 Patients • NCT01605227

35%

Fatigue

32%

Anaemia

30%

Nausea

29%

Constipation

29%

Decreased appetite

20%

Diarrhoea

20%

Vomiting

19%

Back pain

18%

Asthenia

18%

Bone pain

15%

Arthralgia

13%

Oedema peripheral

13%

Dyspnoea

12%

Weight decreased

11%

Pyrexia

11%

Musculoskeletal pain

11%

Pain in extremity

11%

Hypertension

10%

Pain

Urinary tract infection

Insomnia

Prostate cancer

Thrombocytopenia

Hypocalcaemia

Muscle spasms

Muscular weakness

Dizziness

Dysphonia

General physical health deterioration

Abdominal pain upper

Abdominal pain

Dysgeusia

Metastatic pain

Pneumonia

Aspartate aminotransferase increased

Dehydration

Headache

Cough

Hypotension

Dry mouth

Muscosal inflammation

Alanine aminotransferase increased

Hypokalaemia

Depression

Epistaxis

Stomatits

Gastrooesophageal reflux disease

Dyspepsia

Spinal cord compression

Dry skin

Pleural effusion

Metastases to spine

Pulmonary embolism

Myalgia

Hypoaesthesia

Deep vein thrombosis

Pancytopenia

Atrial fibrillation

Multi-organ failure

Sepsis

Septic shock

Liver function test abnormal

Diabetes mellitus

Pathological fracture

Cancer pain

Metastases to central nervous system

Cerebrovascular accident

Paraparesis

Paralpegia

Syncope

Haematuria

Hydronephrosis

Renal failure

Renal failure acute

Infection

Hypomagnesaemia

Palmar-plantar erythrodysaesthesia syndrome

Device related infection

Spinal cord infection

100%

80%

60%

40%

20%

Study treatment Arm

Prednisone

Cabozantinib

Trial Design

25Treatment groups

Experimental Treatment

Group I: Expansion Cohort 9Experimental Treatment2 Interventions

Stage IV nonsquamous NSCLC subjects with sensitizing EGFR mutation who have radiographically progressed during or following prior treatment with an EGFR-targeting TKI. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.

Group II: Expansion Cohort 8Experimental Treatment2 Interventions

Stage IV non-squamous NSCLC subjects with positive PD-L1 expression and without prior systemic anticancer therapy.

Group III: Expansion Cohort 7Experimental Treatment2 Interventions

Stage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior immune checkpoint inhibitor (ICI) (anti-PD-1 or anti-PD-L1) therapy.

Group IV: Expansion Cohort 6Experimental Treatment2 Interventions

CRPC subjects who have radiographically progressed in soft tissue on or after enzalutamide and/or abiraterone acetate for metastatic disease.

Group V: Expansion Cohort 5Experimental Treatment2 Interventions

UC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior immune check-point inhibitor (ICI) (anti-PD1 or anti-PD-L1) therapy.

Group VI: Expansion Cohort 4Experimental Treatment2 Interventions

UC subjects (including bladder, renal pelvis, ureter, urethra) eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.

Group VII: Expansion Cohort 3Experimental Treatment2 Interventions

UC subjects (including bladder, renal pelvis, ureter, urethra) who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.

Group VIII: Expansion Cohort 24Experimental Treatment2 Interventions

Group IX: Expansion Cohort 23Experimental Treatment2 Interventions

Group X: Expansion Cohort 22 (SAA)Experimental Treatment1 Intervention

Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC. Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.

Group XI: Expansion Cohort 21 (SAC)Experimental Treatment1 Intervention

Group XII: Expansion Cohort 20 (SAC)Experimental Treatment1 Intervention

Stage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior ICI (anti-PD-1 or anti-PD-L1). Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.

Group XIII: Expansion Cohort 2Experimental Treatment2 Interventions

UC subjects (including bladder, renal pelvis, ureter, urethra) who have progressed on or after platinum-containing chemotherapy.

Group XIV: Expansion Cohort 19 (SAC)Experimental Treatment1 Intervention

UC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior ICI (anti-PD-1 or anti-PD-L1). Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.

Group XV: Expansion Cohort 18Experimental Treatment2 Interventions

DTC subjects (follicular, papillary, and poorly differentiated histologies) who are radioactive iodine (RAI) refractory or deemed ineligible for treatment with RAI.

Group XVI: Expansion Cohort 17Experimental Treatment2 Interventions

H&N cancer subjects who have radiographically progressed during or following prior platinum-containing chemotherapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.

Group XVII: Expansion Cohort 16Experimental Treatment2 Interventions

CRC subjects who have radiographically progressed during or following systemic chemotherapy that contained fluoropyrimidine in combination with oxaliplatin or irinotecan.

Group XVIII: Expansion Cohort 15Experimental Treatment2 Interventions

GC/GEJC/LEC subjects who have radiographically progressed during or following platinum-containing or fluoropyrimidine-containing chemotherapy.

Group XIX: Expansion Cohort 14Experimental Treatment2 Interventions

HCC subjects (Child-Pugh score A) who have not received prior systemic anticancer therapy.

Group XX: Expansion Cohort 13Experimental Treatment2 Interventions

EC subjects (serous or endometrioid histology) who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy.

Group XXI: Expansion Cohort 12Experimental Treatment2 Interventions

OC subjects (including primary peritoneal cancer and fallopian tube cancer) who have platinum-resistant or refractory disease who have had up to two lines of prior systemic anticancer therapy.

Group XXII: Expansion Cohort 11Experimental Treatment2 Interventions

TNBC subjects who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.

Group XXIII: Expansion Cohort 10Experimental Treatment2 Interventions

RCC subjects with non-clear cell histology who have had up to one prior VEGFR-targeting TKI therapy.

Group XXIV: Expansion Cohort 1Experimental Treatment2 Interventions

RCC subjects with clear cell histology who have not received prior systemic anticancer therapy.

Group XXV: Dose EscalationExperimental Treatment2 Interventions

Subjects will accrue in cohorts of 3-6 subjects for evaluation of cabozantinib tablet dose of either 20 mg, 40 mg, and 60 mg orally qd in combination with standard dosing regimen of atezolizumab (1200 mg infusion q3w). A standard "3 plus 3" design will be utilized to determine a recommended combination dosing regimen for the Expansion Stage.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

atezolizumab

2016

Completed Phase 2

~160

cabozantinib

2011

Completed Phase 3

~1240

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor

117 Previous Clinical Trials

17,819 Total Patients Enrolled

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03170960 — Phase 1 & 2

Gastroesophageal Junction Adenocarcinoma Research Study Groups: Expansion Cohort 10, Expansion Cohort 14, Expansion Cohort 21 (SAC), Expansion Cohort 24, Expansion Cohort 3, Expansion Cohort 16, Expansion Cohort 17, Expansion Cohort 18, Expansion Cohort 19 (SAC), Expansion Cohort 20 (SAC), Expansion Cohort 22 (SAA), Expansion Cohort 23, Expansion Cohort 4, Expansion Cohort 2, Expansion Cohort 12, Expansion Cohort 1, Dose Escalation, Expansion Cohort 5, Expansion Cohort 13, Expansion Cohort 6, Expansion Cohort 7, Expansion Cohort 9, Expansion Cohort 11, Expansion Cohort 15, Expansion Cohort 8

Gastroesophageal Junction Adenocarcinoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03170960 — Phase 1 & 2

Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03170960 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do we have any other data on cabozantinib?

"Cabozantinib was first studied in 2008 by Can Care Assoc Med Group Inc; Beach Cities Offices. As of now, 134 studies have been completed and there are 457 clinical trials still recruiting patients. The majority of these remaining trials are based in Kettering, Ohio."

Answered by AI

How many people are currently enrolled in this experiment?

"As of now, this clinical trial is not looking for any more patients. The first posting was on September 5th, 2017 and the most recent update was on April 8th, 2022. However, there are currently 5372 trials actively recruiting patients with carcinoma, hepatocellular and 457 trials for cabozantinib that have open spots."

Answered by AI

How many medical facilities are running this clinical trial?

"With 57 enrolment centres across Kettering, Phoenix and Gilbert -among other locations- there is bound to be a site close to you. This study's proximity policy helps reduce participant burden by lessening travel requirements."

Answered by AI

Are individuals still being recruited for this research project?

"From what is conveyed on clinicaltrials.gov, this particular medical trial is not looking for more patients at the current time. The first posting was on September 5th, 2017 and the most recent update was April 8th, 2022. Although this specific study isn't recruiting, there are 5829 other trials that are actively seeking candidates."

Answered by AI

What is the first time this particular trial has been conducted?

"Research into cabozantinib began in 2008 with a Phase 1 clinical trial sponsored by Hoffmann-La Roche. After the initial study involving 720 patients, the drug received approval for Phase 2 trials. As of now, there are 457 active trials being conducted in 1957 cities and 75 countries."

Answered by AI

What are the primary conditions that cabozantinib is used to treat?

"Cabozantinib can be used to treat small cell lung cancer (SCLC), as well as conditions such as previously treated with anti-VEGF, malignant neoplasms, and high risk patients."

Answered by AI