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Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors

NCT04007744 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-18

No results posted yet for this study

Summary

This phase I trial studies the best dose of sonidegib when given together with pembrolizumab and to see how well they work in treating patients with solid tumor that has spread to other places in the body (advanced). Sonidegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sonidegib and pembrolizumab may work better than standard treatment in treating patients with advanced solid tumors.

Conditions

  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Locally Advanced Gastric Adenocarcinoma
  • Locally Advanced Gastroesophageal Junction Adenocarcinoma
  • Locally Advanced Urothelial Carcinoma
  • Metastatic Gastric Adenocarcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Melanoma
  • Metastatic Urothelial Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Refractory Lung Non-Small Cell Carcinoma
  • Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Unresectable Malignant Solid Neoplasm
  • Unresectable Melanoma

Interventions

BIOLOGICAL

Pembrolizumab

Given IV

DRUG

Sonidegib

Given PO

Sponsors & Collaborators

Principal Investigators

  • Mojun Zhu, M.D. · Mayo Clinic in Rochester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2025-05-08
Completion
2027-07-02
FDA Drug
Yes

Countries

  • United States

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 NCT04007744 on ClinicalTrials.gov