A Study of Durvalumab Plus Tremelimumab With Chemotherapy in Untreated ES-SCLC

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT03963414
Phase
PHASE1
Status
Terminated

Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

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

Interventions

Study Details

This study is designed to evaluate the safety and tolerability of durvalumab and tremelimumab in combination with intravenous (IV) carboplatin plus (+) etoposide in new patients with extensive-stage small cell lung cancer (ES-SCLC).

Key Dates

Start date
Sep 25, 2020
Status verified
Aug 2023
Primary completion
Dec 15, 2021
Completion
Dec 15, 2021

Study Design

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

Arms

  • Experimental: Cohort 1
    Durvalumab 1500 mg via IV infusion every 3 weeks, starting on Week 7, for up to a maximum of 2 doses/cycles followed by durvalumab maintenance monotherapy 1500 mg via IV infusion every 4 weeks, starting 4 weeks after Cycle 4.
  • Experimental: Cohort 2
    Durvalumab 1500 mg plus tremelimumab 75 mg via IV infusion every 3 weeks, starting on Week 7, for up to a maximum of 2 doses/cycles followed by durvalumab monotherapy 1500 mg via IV infusion every 4 weeks, starting 4 weeks after the last infusion of the combination.

Primary Outcome Measure

Incidence of Treatment-related Adverse Events with a Severity of 3 or higher (Safety and tolerability) [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198-

Find similar trials in Omaha, NE

By research site
University of Nebraska Medical Center· Omaha, NE

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