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Ribociclib and Spartalizumab in R/M HNSCC

NCT04213404 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-04-21

No results posted yet for this study

Summary

This study examines the safety and efficacy of ribociclib (CDK 4/6 inhibitors) and spartalizumab (anti-PD1) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Conditions

Interventions

DRUG

Ribociclib

Ribociclib 400mg, 600mg, or 200mg oral daily, D1-D21, 28 days a cycle

DRUG

Spartalizumab

Spartalizumab 400mg ivdrip on D1, 28 days a cycle.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Hsiang-Fong Kao, MD · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-13
Primary Completion
2024-01-31
Completion
2025-01-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04213404 on ClinicalTrials.gov