Phase Ib/IIa Trial to Evaluate Oregovomab and Nivolumab in Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin

Sponsor
National Cancer Centre, Singapore
Study ID
NCT03100006
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    240mg of IV Nivolumab is administered over 30 mins every 2 weeks
  • Oregovomab — DRUG
    IV Oregovomab is administered over 20 mins every 4 weeks at dose levels: 2mg, 1mg, or 0.5mg

Study Details

The purpose of this study is to characterize the safety and tolerability, identify a recommended dose for expansion (RDE) / recommended phase II dose (RP2D), pharmacodynamics, and antitumor activity of Oregovomab vaccination in combination with Nivolumab as a novel combinatorial immunotherapeutic strategy in in female patients with recurrent epithelial ovarian cancer (EOC) who progressed after two or more prior lines of cytotoxic chemotherapy.

Key Dates

Start date
Feb 22, 2017
Status verified
Jun 2022
Primary completion
Jun 7, 2019
Completion
Apr 17, 2020

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and Oregovomab

Primary Outcome Measure

Number of incidences and severity of Adverse Events (AE) and Serious AEs that are treatment-related, graded based on the CTCAE v4.03 [ Time Frame: 4 weeks from the start of treatment ]

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