A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Ludwig Institute for Cancer Research
Sponsor:
Collaborators:
MedImmune LLC
Cancer Research Institute, New York City
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT01975831
First received: October 29, 2013
Last updated: July 11, 2014
Last verified: July 2014

October 29, 2013
July 11, 2014
December 2013
December 2016   (final data collection date for primary outcome measure)
Number of adverse events [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01975831 on ClinicalTrials.gov Archive Site
  • Area under the concentration time curve, maximum concentration, clearance, half-life after administration of MEDI4736 and Tremelimumab [ Time Frame: Up to 15 months ] [ Designated as safety issue: No ]
  • Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs) [ Time Frame: Up to 15 months ] [ Designated as safety issue: Yes ]
  • Tumor Response by the Immune-related Response Criteria [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Tumor Response using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Progression-free Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab
A Phase 1 Study to Evaluate the Safety and Tolerability of Anti-PD-L1, MEDI4736, in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

This is a multicenter, open-label, study with a standard 3+3 dose-escalation phase, followed by an expansion phase in subjects with solid tumors

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
  • Drug: MEDI4736
  • Drug: Tremelimumab
Experimental: MEDI4736 & Tremelimumab Treatment
MEDI4736 and Tremelimumab will be administered by IV infusion
Interventions:
  • Drug: MEDI4736
  • Drug: Tremelimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
102
Not Provided
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically- or cytologically-confirmed solid tumor with at least one measurable lesion.
  • Failed to respond to or relapsed following standard treatment, or declined or was not eligible for standard treatment.
  • ECOG performance status of 0-2.
  • Anticipated lifespan greater than 6 month.
  • Adequate organ and marrow function
  • Able and willing to give valid written informed consent.
  • Able and willing to give valid written consent for archival tumor samples
  • Able and willing to give valid written consent for biopsy samples (subjects in the expansion phase only).

Exclusion Criteria:

  • Prior exposure to Tremelimumab or MEDI4736 or other anti-CTLA-4, anti-PD-1, anti-PD-L1 antibodies
  • History of severe allergic reactions to any unknown allergens.
  • Active or prior autoimmune disease except for autoimmune thyroiditis or vitiligo.
  • Any prior Grade ≥ 3 immune-related adverse event (irAE) or any prior corticosteroid-refractory irAE.
  • Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months.
  • History of sarcoidosis syndrome.
  • Active or history of inflammatory bowel disease (colitis, Crohn's), diverticulitis, irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea. Active or history of systemic lupus erythematosus or Wegener's granulomatosis.
  • Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available.
  • Known immunodeficiency or active HIV.
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to day 1 of the study.
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Women who are breast feeding or pregnant
  • Women of childbearing potential not using a medically acceptable means of contraception for the duration of the study.
Both
18 Years and older
No
Contact: Andrew Park, PharmD 2124501587 apark@licr.org
United States
 
NCT01975831
LUD2013-003
No
Ludwig Institute for Cancer Research
Ludwig Institute for Cancer Research
  • MedImmune LLC
  • Cancer Research Institute, New York City
Study Chair: Jedd Wolchok, MD, PhD MSKCC
Ludwig Institute for Cancer Research
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP