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Table 1 General and cohort specific study inclusion criteria

From: Precision medicine phase II study evaluating the efficacy of a double immunotherapy by durvalumab and tremelimumab combined with olaparib in patients with solid cancers and carriers of homologous recombination repair genes mutation in response or stable after olaparib treatment

Inclusion criteria

 General step 1

  1 Patients > 18 years at time of inclusion capable of giving signed informed consent.

  2 Performance status ECOG of 0 or 1.

  3 Life expectancy ≥6 months.

  4 Body weight > 30 kg.

  5 Patients diagnosed with a solid malignancy, histologically confirmed (see cohort specific inclusion criteria below).

  6 Presence of mutation in homologous repair gene (BRCA1, BRCA2, PALB2, ATM, FANCA, FANCB, FANCC, FANCE, FANCF, CHEK2, RAD51, BARD1, MRE11, RAD50, NBS1, HDAC2), LKB1/STK11, INPP4B, STAG2, ERG, CHEK1, BLM, LIG4, ATR, ATRX, CDK12). Homozygote or heterozygote mutations and loss of heterozygosity of the second allele accepteda.

  7 At least one lesion measurable as defined by standard imaging criteria for the patient’s tumor type (RECIST v1.1) that can be accurately assessed at baseline and suitable for repeated assessment.

  8 Patients must have normal organ and bone marrow function.

  9 Female and male with adequate contraception method.

  10 For all oral medications patients must be able to comfortably swallow capsules.

  11 Patients affiliated to a social security regimen or beneficiary of the same according to local requirements.

 General step 2

  12 CT Scan evaluation after 6 weeks of olaparib should present response or stable disease as defined by RECIST v1.1 criteria.

Inclusion criteria

 Cohort specific

  Breast cancerbd

  - 2nd line and after

Lung cancerbd

- Non-small cell lung cancer.

- Must have progressed after at least a first line with platinum based therapy.

Head and neck cancerbd

- Must have progressed after at least a 1st line with platinum based therapy.

  Metastatic endometrial cancerbd

  - Progression after one prior systemic, platinum-based chemotherapy.

Clear cell renal cancerbd

- Must have progressed after at least a line with anti-angiogenic agent.

Pancreatic cancerbd

- Must have progressed after at least a line with FOLFIRINOX regimen and/or Gemcitabine based chemotherapy.

  Ovarian cancerce

  - Must have received at least one and no more than two lines of prior platinum-containing therapy and progressed after the most recent platinum therapy in a platinum-sensitive timeframe (more than 6 months from the last dose of platinum before randomization).

Urothelial cancerbd

- -2nd line and after.

Prostate cancerbd

- Documented evidence of metastatic castration resistant prostate cancer (mCRPC).

- Ongoing therapy with LHRH analog or bilateral orchiectomy.

Must have progressed on prior new hormonal agent (enzalutamine or abiraterone) and taxane chemotherapy.

  1. a With patient consent, exome sequencing of tumor and constitutive DNA should have been already performed during prior patient medical care, either as part of a clinical study or in accordance with the usual practice at investigator site, and should comprise the mandatory gene list indicated in inclusion criteria 6
  2. b Metastatic; c Locally advanced or metastatic; d ≥2nd treatment line; e 2nd or 3rd treatment line
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BMC Cancer

ISSN: 1471-2407

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