Patient case: 68-year-old male with colon cancer; genetic feature: MLH1 methylation suppression (microsatellite instability)

Clinical trial: An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors

Summary: The purpose of the dose escalation part of this study is to determine the feasibility of using the combination of copanlisib and nivolumab in subjects with advanced solid tumors, and to determine the maximum tolerated dose of copanlisib in combination with nivolumab. The maximum tolerated dose will then be used in Phase 2 (dose expansion) of the study.


Eligibility: Inclusion Criteria:
  -  Participants with a histologically confirmed diagnosis of:
  Phase 1b:
  -  Advanced solid tumors where nivolumab is indicated as per the latest nivolumab Prescribing Information,
  Phase 2:
  -  Metastatic NSCLC, relapsed after prior platinum containing chemotherapy, irrespective of PD-L1 expression AND non-responding (no CR/PR) nonprogressing (no PD) on current nivolumab treatment. Patients with Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations. Participants must have been on nivolumab therapy for at least 3 months prior to screening.
  -  Recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy
  -  Microsatellite instability-high (MSI-H)/ Mismatch repair deficient) dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
  -  HCC previously treated with Sorafenib
  Exclusion Criteria:
  -  Active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  -  Major surgery, open biopsy or significant traumatic injury ≤ 28 days prior to first administration of study intervention. Central line surgery is not considered major surgery
  -  Symptomatic metastatic brain or meningeal carcinomatosis or tumors unless the participant is > 6 months from definitive therapy (surgery or radiotherapy), has no evidence of tumor growth on an imaging study and is clinically stable with respect to the tumor at the start of study intervention.
  -  Other malignancy within the last 5 years except for the following, which are permitted:
  -  curatively treated basal cell/squamous cell skin cancer,
  -  carcinoma in situ of the cervix,
  -  superficial transitional cell bladder carcinoma (if BCG [Bacillus Calmette-Guerin] treatment was given, there should be a minimum of 6 months between last dose and enrollment),
  -  in situ ductal carcinoma of the breast after complete resection,
  -  participants with localized, resected and/or low-risk prostate cancer may be eligible after discussion with the sponsor's designated medical representative and sponsor's approval.
  -  Other protocol inclusion/exclusion criteria may apply

Relevance to patient case: not relevant