A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer

ClinicalTrials.gov ID

NCT02000947

Acronym / sponsor ID

D4190C00006 / D4190C00006

Conditions

NSCLC, Non-small Cell Lung Cancer, Lung Cancer

Keywords

anti-CTLA-4, anti-PD-L1, immunotherapy, IMTC

Phase

Phase 1

Study type

Interventional

Recruitment status

Completed

Enrolment

459 participants (actual)

Lead sponsor

MedImmune LLCIndustry (pharma, biotech, devices)

Study start

25 Oct 2013 (actual)

Primary completion

17 Sep 2019 (actual)

Study completion

17 Sep 2019 (actual)

First posted

4 Dec 2013 (estimated)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

4

Who may qualify

Ages

18 to 101 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of subjects reporting adverse events

   Time frame: Screening through 90 days after the last dose of study medication

   The number of subjects reporting adverse events (AEs) and number (percentage) of subjects reporting serious adverse events (SAEs) as graded by CTCAE Version 4.03

2. Objective response

   Time frame: At least 24 weeks as compared to baseline

   Best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as defined as the best response among all overall responses recorded from the start of treatment until progression, or the last evaluable disease assessment in the absence of progressive disease (PD) prior to the initiation of subsequent anti-cancer therapy, or discontinuation from the study, whichever occurs first.

3. Number of subjects experiencing dose-limiting toxicities (DLTs)

   Time frame: Depending upon the cohort, the DLT evaluation period is from the 1st dose of study medication until (1) the 3rd dose of MEDI4736 and tremelimumab (2) the 2nd dose of MEDI4736 and tremelimumab or (3) the 3rd dose of MEDI4736 and 2nd dose of tremelimumab

   The maximum tolerated dose (MTD), which is the highest dose within a cohort where no more than 1 out of 6 subjects experience DLTs or the highest protocol-defined dose for each agent in the absence of exceeding the MTD, will be evaluated using the following safety assessments: adverse events, serious advents, laboratory evaluations, vital signs, physical examinations, and electrocardiogram (ECG) results. Measurements will be aggregated to determine whether a subject has experienced a DLT as assessed by the investigator.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
• Derived from this study: PubMed 37146752Garon EB, Spira AI, Goldberg SB, Chaft JE, Papadimitrakopoulou V, Cascone T, Antonia SJ, Brahmer JR, Camidge DR, Powderly JD, Wozniak AJ, Felip E, Wu S, Ascierto ML, Elgeioushi N, Awad MM. Brief Report: Safety and Antitumor Activity of Durvalumab Plus Tremelimumab in Programmed Cell Death-(Ligand)1-Monotherapy Pretreated, Advanced NSCLC: Results From a Phase 1b Clinical Trial. J Thorac Oncol. 2023 Aug;18(8):1094-1102. doi: 10.1016/j.jtho.2023.04.020. Epub 2023 May 4.
• Derived from this study: PubMed 26858122Antonia S, Goldberg SB, Balmanoukian A, Chaft JE, Sanborn RE, Gupta A, Narwal R, Steele K, Gu Y, Karakunnel JJ, Rizvi NA. Safety and antitumour activity of durvalumab plus tremelimumab in non-small cell lung cancer: a multicentre, phase 1b study. Lancet Oncol. 2016 Mar;17(3):299-308. doi: 10.1016/S1470-2045(15)00544-6. Epub 2016 Feb 6.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

69 sites in 9 countries: see every site and its status.