Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer

Conditions

• Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ipilimumab — BIOLOGICAL

Study Details

To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment

Key Dates

Start date

Aug 21, 2012

Status verified

Jul 2020

Primary completion

Nov 3, 2014

Completion

Jul 3, 2019

Study Design

Enrollment

40 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arm: Ipilimumab, 10 mg/kg
  Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.

Primary Outcome Measure

Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher [ Time Frame: Day 1, first dose, to within 90 days of last dose in Induction Phase ]

Locations (17)

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