Preoperative Administration of Olaparib With Cisplatin or With Durvalumab or Alone or no Tratment in Patients Who Are Candidates for Surgery of Carcinoma of the Head and Neck.

Sponsor
Hellenic Cooperative Oncology Group
Study ID
NCT02882308
Phase
PHASE2
Status
Completed

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    50/25 mg BD split x 5 days
  • Cisplatin — DRUG
    60 mg/m\^2 d1-d5
  • Olaparib — DRUG
    300 mg BD x 21-28 days.
  • Durvalumab — DRUG
    1500 mg d1

Study Details

OPHELIA (OPHELIA (OlaParib and durvalumab in HEad and neck squamous celL carcInomA) trial is a Greek, investigator-initiated, randomized open-label window-of-opportunity phase II study. Patients with operable histologically documented squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx will be randomized between combination with durvalumab and olaparib, cisplatin and olaparib, monotherapy with olaparib or no treatment, before starting standard treatment.

Key Dates

Start date
Oct 20, 2016
Status verified
Feb 2020
Primary completion
Dec 31, 2019
Completion
Jan 10, 2020

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy with olaparib
    Patients in the monotherapy arm will be treated with olaparib until the 21st -28th day depending on the day of surgery, will be reassessed by imaging (tumour objective response by RECIST) on the 22nd -28th day and then have a second biopsy or be operated on the 23rd - 29th day. If surgery is delayed, olaparib will be continued until the day before surgery.
  • Experimental: Combination of cisplatin and olaparib
    Patients in the cisplatin - olaparib combination arm will receive treatment until the 5th day, will be reassessed by imaging (tumour objective response by RECIST) on the 22nd -28th day and then will have a second biopsy or be operated on the 23rd - 29th day.
  • No Intervention: No treatment arm
    Patients in the "no treatment" arm will wait to be operated or have a second biopsy on the 23rd - 29th day.Optionally, patients who have a baseline FDG-PET/CT scan may be re-examined on the 22nd -28th day by the same modality to assess metabolic response.
  • Experimental: Combination of durvalumab and olaparib
    Patients in the durvalumab - olaparib combination arm will receive treatment until the 21th-28th day, will be reassessed by imaging (tumour objective response by RECIST) on the 22nd -28th day and then will have a second biopsy or be operated on the 23rd - 29th day. If surgery is delayed, olaparib will be continued until the day before surgery.

Primary Outcome Measure

Investigation of the change in the tumour Ki-67 before and after treatment with the combination of olaparib + durvalumab or olaparib + cisplatin or olaparib monotherapy. [ Time Frame: At baseline and at the day of the surgery or 2nd biopsy (at days 23-29 days) ]

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