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A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer

Trial Status: Active

This study will assess the safety and preliminary efficacy of duvelisib in combination with pembrolizumab in subjects with recurrent or metastatic (R / M) head and neck squamous cell carcinoma (HNSCC).

Inclusion Criteria

  • Age ≥ 18 years, ECOG performance status ≤ 1
  • Histologically or cytologically-confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies
  • Eligible for pembrolizumab monotherapy based on the current prescribing information for pembrolizumab (Keytruda 2019)
  • Must have had 0 to 2 prior therapies for R/M HNSCC.
  • At least 1 measurable lesion (which has not been previously irradiated) according to RECIST v 1.1
  • For stage 1 only: Must have at least 1 other lesion that can be biopsied and willing to undergo a pretreatment and on-treatment biopsy of the available tumor lesion
  • For stage 1 only: Must be willing to undergo a pretreatment and on-treatment biopsy of the available tumor lesion
  • Adequate organ function defined by the following laboratory parameters:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
  • Platelet count ≥ 100 × 109/L
  • Hemoglobin level ≥ 9.0 g/dL
  • A serum creatinine level < 1.5 mg/dL, or
  • Estimated creatinine clearance value ≥ 60 mL/min (as determined by the Cockcroft-Gault method) for subjects with creatinine levels > 1.5 × institutional upper limit of normal (ULN)
  • Total bilirubin level ≤ 1.5 × ULN (exception: subjects with Gilbert's Syndrome may have a bilirubin level > 1.5 × ULN)
  • Aspartate aminotransaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum pyruvic transaminase (SGPT) levels ≤ 2.5 × ULN or ≤ 5 × ULN in subjects with liver metastases
  • International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, unless subject is receiving anticoagulant therapy in which case PT or aPTT must be within therapeutic range of intended use of anticoagulants

Exclusion Criteria

  • Previously treated with 3 or more systemic regimens given for recurrent and/or metastatic disease
  • Received anticancer treatment, major surgery, or any investigational drug within 30 days or 5 half-lives, whichever is shorter, before the start of study intervention
  • Received radiation therapy within 14 days before the start of study intervention, including, in addition (if necessary), the timeframe for resolution of any actual or anticipated toxicities from such radiation; Palliative radiation is allowed if > 7 days and any toxicity is ≤ Grade 1
  • Previous treatment with a PI3K, PD-1 or PD-L1 inhibitor
  • Have received organ or allogenic bone marrow or peripheral blood stem cell transplant
  • History of drug-induced colitis or drug-induced pneumonitis; history or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function; tuberculosis treatment within 2 years prior to the start of study intervention; chronic liver disease or veno-occlusive disease/sinusoidal obstruction syndrome
  • Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection; history of or known human immunodeficiency virus (HIV) infection
  • Ongoing treatment with chronic immunosuppressants or systemic steroids or treatment for systemic bacterial, fungal, or viral infection
  • Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
  • Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start of study intervention Received a live or live attenuated vaccine within 6 weeks of first dose of duvelisib
  • Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
  • Any active gastrointestinal dysfunction interfering with the subject's ability to be administered oral medications
  • Known active central nervous system metastases and/or carcinomatous meningitis
  • QT interval > 500 ms (except for subjects with a right or left bundle branch block)
  • New York Heart Association Class III or IV congestive heart failure

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Kyle Fredericks
Phone: 412-623-7173

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

This is a multicenter, non-randomized, open-label Phase 1b/2 study designed to evaluate safety and tolerability and preliminary efficacy of duvelisib in combination with pembrolizumab in subjects with R/M HNSCC who are eligible for pembrolizumab monotherapy based on the current pembrolizumab prescribing information.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Verastem Inc

  • Primary ID VS-0145-130
  • Secondary IDs NCI-2020-01984
  • Clinicaltrials.gov ID NCT04193293