SNPMiner Trials (Home Page)
Report for Clinical Trial NCT02882308
 Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene 
      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.
    
Name: Olaparib
Description: 50/25 mg BD split x 5 days
 Type: Drug
Group Labels:  1  Combination of cisplatin and olaparib  
 Name: Cisplatin
Description: 60 mg/m^2 d1-d5
 Type: Drug
Group Labels:  1  Combination of cisplatin and olaparib  
 Name: Olaparib
Description: 300 mg BD x 21-28 days.
 Type: Drug
Group Labels:  2  Combination of durvalumab and olaparib  Monotherapy with olaparib  
 Name: Durvalumab
Description: 1500 mg d1
 Type: Drug
Group Labels:  1  Combination of durvalumab and olaparib  
  
Primary Outcomes 
 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: At baseline and at the day of the surgery or 2nd biopsy (at days 23-29 days)
   
Secondary Outcomes 
 Measure: Objective response rate according to RECIST 1.1 criteria Time: Imaging studies will be performed at baseline and on week 4
 Measure: Pathologic complete response rate Time: On week 4 only for operable patients
 Measure: Metabolic response rate assessed by FDG-PET/CT scan (optional) Time: At baseline, on week 4
 Measure: Number of participants with tolerability to the treatment. Time: From the 1st day of therapy and every week for 4 weeks maximum and 90 days after last therapy administration
 Measure: Surgical complication rate Time: Up to 30 days after surgery or the day of initiation of the next anticancer therapy
 Measure: Mutations in genes associated with DNA repair Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
 Measure: Expression of tissue biomarker: PARP1 Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
 Measure: Expression of tissue biomarker: BRACA1,2 Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
 Measure: Expression of tissue biomarker: ERCC1 Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
 Measure: Expression of tissue biomarker: PDL-1 Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
 Measure: Expression of tissue biomarker: TILs Time: At baseline, on day of surgery or the 2nd biopsy (at days 23-29)
 Measure: Plasma methylation biomarker: PARP1 methylation in plasma cell-free DNA Time: At baseline, a day before surgery and 90 days after surgery
 Measure: Plasma methylation biomarker: BRCA1,2 methylation in plasma cell-free DNA Time: At baseline, a day before surgery and 90 days after surgery
 Measure: Plasma methylation biomarker: ERCC1 methylation in plasma cell-free DNA Time: At baseline, a day before surgery and 90 days after surgery
 Measure: Plasma methylation biomarker: RAD51C methylation in plasma cell-free DNA Time: At baseline, a day before surgery and 90 days after surgery
 Measure: Single-nucleotide polymorphisms: PARP-1 Val762Ala Time: Sample will be collected once at baseline
 Measure: Single-nucleotide polymorphisms: ERCC1 Asn118Asn (C/T) Time: Sample will be collected once at baseline
 Measure: Single-nucleotide polymorphisms:ERCC2 Lys751Gln (T/G) Time: Sample will be collected once at baseline
 Measure: Single-nucleotide polymorphisms: GSTP1 Ile105Val (A/G) Time: Sample will be collected once at baseline
 Measure: Single-nucleotide polymorphisms: XPD Lys751Gln (A/C, C/C) Time: Sample will be collected once at baseline
 Measure: Single-nucleotide polymorphisms: XRCC1 Arg399Gln (G/A) Time: Sample will be collected once at baseline
 Measure: Circulating tumor cells (CTCs) evaluated for DNA repair biomarkers Time: At baseline, a day before surgery and 90 days after surgery
 Measure: Circulating tumor cells (CTCs) evaluated for PD-L1 Time: At baseline, a day before surgery and 90 days after surgery
 
Purpose: Treatment
Allocation: Randomized
Factorial Assignment 
There are 4 SNPs
SNPs
1 I105V 
Single-nucleotide polymorphisms: GSTP1 Ile105Val (A/G). --- Ile105Val --- 
 Single-nucleotide polymorphisms:ERCC2 Lys751Gln (T/G). --- Lys751Gln --- 
Single-nucleotide polymorphisms: XPD Lys751Gln (A/C, C/C). --- Lys751Gln ---