SNPMiner Trials (Home Page)
Report for Mutation V762A
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 Phase II(Window) Preoperative Study of Olaparib With Cisplatin or With Durvalumab (MEDI4736) or Alone or no Treatment in Patients With Histologically Proven Squamous Cell Carcinoma of the Head and Neck Who Are Candidates for Surgery.
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.
NCT02882308 Squamous Cell Carcinoma of the Head and Neck Drug: Olaparib Drug: Cisplatin Drug: Olaparib Drug: Durvalumab MeSH:Carcinoma Carcinoma, Squamous Cell Squamous Ce Squamous Cell Carcinoma of Head and Neck
HPO:Carcinoma Squamous cell carcinoma
Single-nucleotide polymorphisms: PARP-1 Val762Ala. --- Val762Ala ---
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 4Measure: 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