Treatment (nivolumab and cabozantinib) for Squamous cell carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Squamous cell carcinoma+59 More
Computed Tomography - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that has spread to other places in the body (advanced). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine how quickly patients can be divided into groups based on biomarkers in their tumors. A biomarker is a biological molecule found in the blood, other body fluids, or in tissues that is a sign of a normal or abnormal process or a sign of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. The two biomarkers that this trial is studying are "tumor mutational burden" and "tumor inflammation signature." Another purpose of this trial is to help doctors learn if cabozantinib and nivolumab shrink or stabilize the cancer, and whether patients respond differently to the combination depending on the status of the biomarkers.

Eligible Conditions
  • Squamous cell carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Hypopharyngeal Squamous Cell Carcinoma
  • Stage IVC Hypopharyngeal Carcinoma AJCC v8
  • Carcinoma
  • Malignant neoplasm of larynx
  • Oropharyngeal Squamous Cell Carcinoma
  • Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Metastatic Cutaneous Melanoma
  • Cutaneous Melanoma
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Recurrent Cutaneous Melanoma
  • Stage IVA Hypopharyngeal Carcinoma AJCC v8
  • Malignant Neoplasms
  • Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Unresectable Cutaneous Melanoma
  • Metastatic Laryngeal Squamous Cell Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Metastatic Hypopharyngeal Squamous Cell Carcinoma
  • Metastatic Oropharyngeal Squamous Cell Carcinoma
  • human papillomavirus
  • Stage IVB Hypopharyngeal Carcinoma AJCC v8
  • Stage III Hypopharyngeal Carcinoma AJCC v8
  • Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Recurrent Oral Cavity Squamous Cell Carcinoma
  • Stage III Lip and Oral Cavity Cancer AJCC v8
  • Stage IV Hypopharyngeal Carcinoma AJCC v8
  • Stage IVA Lip and Oral Cavity Cancer AJCC v8
  • Stage IVB Lip and Oral Cavity Cancer AJCC v8

Treatment Effectiveness

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Up to 2 years

Assessed within 21 days
Turnaround time for the Tumor Inflammation Score (TIS) in stage I
At the end of stage I
Objective response rate
Year 2
Overall survival (OS)
Year 2
Progression-free survival (PFS)
Day 21
Success rate of biomarker result turnaround time in stage I and overall
Day 21
Biomarker results turnaround time
Up to 2 years
Disease control rate (DCR)
Rate and profile of >= grade 3 treatment-related adverse events (TRAE)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (nivolumab and cabozantinib)
1 of 1

Experimental Treatment

150 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (nivolumab and cabozantinib) · No Placebo Group · Phase 2

Treatment (nivolumab and cabozantinib)Experimental Group · 6 Interventions: Computed Tomography, Magnetic Resonance Imaging, Biopsy, Biospecimen Collection, Nivolumab, Cabozantinib S-malate · Intervention Types: Procedure, Procedure, Procedure, Procedure, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3410
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Biopsy
2014
Completed Phase 4
~1120
Biospecimen Collection
2004
Completed Phase 1
~670
Nivolumab
FDA approved
Cabozantinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,995 Previous Clinical Trials
41,299,786 Total Patients Enrolled
Siwen Hu-LieskovanPrincipal InvestigatorSouthwest Oncology Group
1 Previous Clinical Trials
47 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Specimen submission must be accompanied by a valid medical certificate
Participants must have disease presentation consistent with measurable disease
You are HIV-positive and receiving anti-retroviral therapy.
You are eligible if you are at least 18 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: November 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.