Clinical Trial 17985

Cancer Type: Multiple
Interventions:INCB024360 (Epacadostat); MEDI4736 (Durvalumab)

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

  • Benjamin Creelan

Overview

Study Title

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCB024360 in Combination With MEDI4736 in Subjects With Selected Advanced Solid Tumors

Summary

The primary purposes of this research study is to assess how safe and well tolerated the study drugs Epacadostat and Durvalumab are when combined and given together in patients with previously treated lung cancer, melanoma, head and neck cancer, or pancreatic cancer. The other goals of this study are to determine a tolerated dose of this combination to be further explored, and to assess if these types of cancer respond to the combination of study drugs.

Objective

Primary Objectives: Phase 1: To evaluate the safety and tolerability, and define the maximum tolerated dose (MTD) or a pharmacologically active dose (PAD) of INCB024360 administered in combination with MEDI4736 in subjects with select advanced solid tumors. Phase 2: To evaluate the efficacy of INCB024360 administered in combination with MEDI4736 in subjects with select advanced solid tumors by assessing the objective response rate (ORR) per modified RECIST v1.1 (mRECIST v1.1) at the MTD or PAD.

Inclusion Criteria

  • Males or females, age 18 years or older.
  • Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors.
  • Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment (refusal does not apply to participants in Phase 1).

  • Exclusion Criteria

  • Laboratory and medical history parameters not within protocol-defined range.
  • Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
  • Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor (exception is tumor types in which a PD-1 pathway targeted agent is approved, e.g. melanoma, non-small cell lung cancer.)
  • Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication.
  • Has any active or inactive autoimmune process.
  • Evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Prior radiotherapy within 2 weeks of initiating treatment; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
  • Untreated central nervous system (CNS) metastases or CNS metastases that have progressed.
  • Currently pregnant or breastfeeding.