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A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer (D4190C00006)

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MedImmune

Status and phase

Completed
Phase 1

Conditions

Non-small Cell Lung Cancer
Lung Cancer
NSCLC

Treatments

Drug: MEDI4736
Drug: tremelimumab
Drug: Tremelimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02000947
D4190C00006
2015-003715-38 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).

Full description

This is a multicenter, open-label, dose-escalation, and dose expansion study of MEDI4736 in combination with tremelimumab to evaluate the safety, tolerability, pharmacokinetic (PK), immunogenicity, and antitumor activity of MEDI4736 in combination with tremelimumab in adult subjects with advanced NSCLC.

Enrollment

459 patients

Sex

All

Ages

18 to 101 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age ≥ 18 years
  2. Advanced non-small cell lung cancer
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  4. Adequate organ and marrow function

Exclusion criteria

  1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
  2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
  3. Active or prior documented autoimmune disease within the last 2 years.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

459 participants in 4 patient groups

Dose Escalation
Experimental group
Description:
MEDI4736 and tremelimumab received by intravenous infusion.
Treatment:
Drug: MEDI4736
Drug: Tremelimumab
Arm A
Experimental group
Description:
Medi4736 and tremelimumab received by intravenous infusion
Treatment:
Drug: MEDI4736
Drug: Tremelimumab
Arm B
Experimental group
Description:
MEDI4736 and tremelimumab received by intravenous infusion
Treatment:
Drug: MEDI4736
Drug: tremelimumab
Arm C
Experimental group
Description:
MEDI4736 and tremelimumab received by intravenous infursion
Treatment:
Drug: MEDI4736
Drug: tremelimumab

Trial contacts and locations

69

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Data sourced from clinicaltrials.gov

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