Clinical Trial 18758

Cancer Type: Thoracic
Interventions:PF-04518600; PF-05082566 (utomilumab)

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Alberto Chiappori

Overview

Study Title

A Phase 1, Open-Label Dose Escalation Study of PF-04518600 as a Single Agent and in Combination with PF-05082566 in Patients with Selected Locally Advanced or Metastatic Carcinomas

Summary

To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination with PF-05082566 in participants with select advanced or metastatic carcinoma.

Objective

Objectives for Part A1 Monotherapy Dose Escalation - Primary Objective: *To assess safety, and tolerability at increasing dose levels of PF-04518600 in patients with selected advanced or metastatic solid tumors in order to establish the MTD. Objectives for Part A2 Monotherapy Dose Expansion - Primary Objectives: *To establish the recommended phase 2 dose (RP2D) of PF-04518600 in patients with selected advanced or metastatic solid tumors. *To further characterize the safety and tolerability of PF-04518600 in patients with selected advanced or metastatic solid tumors. Objectives for Part B1 Combination Therapy Dose Escalation - Primary Objective: *To assess safety and tolerability at increasing dose levels of PF-04518600 in combination with PF-05082566 in patients with selected advanced or metastatic solid tumors and to estimate MTD of the combination. Objectives for Part B2 Combination Therapy Dose Expansion - Primary Objective: *To further assess safety and tolerability of PF-04518600 in combination with PF-05082566 in patients with selected advanced or metastatic solid tumors in order to establish RP2D for the combination.

Inclusion Criteria

  • Age 18 years or older
  • Diagnosis of hepatocellular carcinoma (HCC), melanoma, clear cell renal cell carcinoma (RCC), head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), melanoma, urothelial bladder carcinoma, gastric or squamous cell carcinoma of the uterine cervix who progressed on or are intolerant to standard therapy, for which no standard therapy is available or who decline standard therapy.
  • Performance Status of 0 or 1 - Adequate bone marrow, kidney and liver function

  • Exclusion Criteria

  • Brain metastases requiring steroids
  • Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
  • Active and clinically significant bacterial, fungal, or viral infection