Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-repair Proficient (MSS) Colorectal Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03711058
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Microsatellite Stable (MSS) Colon Cancer
  • Unresectable or Metastatic Microsatellite Stable (MSS) Solid Tumor

Eligibility Criteria

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

Interventions

  • Copanlisib — DRUG
    Copanlisib will be administered as a 60 minute IV infusion (-5min/+10min) at a dose of 45 mg - 60 mg IV. Copanlisib will be administered once a week (days 1, 8, and 15 or Day 1 and Day 15 of each 28 day cycle). Drug: 45 or 60 mg IV
  • Nivolumab — DRUG
    Nivolumab 480 mg will be administered as a 30 minute IV infusion (-5min/+10min) on Day 1 of each 28 day cycle. Drug: 480 mg IV

Study Details

A phase I/II study of PI3Kinase inhibition (copanlisib) and anti-PD-1 antibody nivolumab in relapsed/refractory solid tumors with expansions in mismatch-repair proficient (MSS) colorectal cancer.

Key Dates

Start date
Jan 17, 2019
Status verified
Aug 2025
Primary completion
Jun 14, 2022
Completion
Jun 30, 2025

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I - Copanlisib and Nivolumab (De-Escalation)
  • Experimental: Phase II /Arm A-P13K mutation/Copanlisib and Nivolumab
  • Experimental: Phase II/Arm B -P13K wild type /Copanlisib and Nivolumab

Primary Outcome Measure

Number of Participants Experiencing a Dose Limiting Toxicity [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-

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Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD