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
  Purpose

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


Condition Intervention Phase
Solid Tumors
Drug: MEDI4736
Drug: Tremelimumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 102
Study Start Date: December 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI4736 & Tremelimumab Treatment
MEDI4736 and Tremelimumab will be administered by IV infusion
Drug: MEDI4736 Drug: Tremelimumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975831

Contacts
Contact: Andrew Park, PharmD 2124501587 apark@licr.org

Locations
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States
United States, New York
Research Site Recruiting
Buffalo, New York, United States
Research Site Recruiting
New York, New York, United States
Sponsors and Collaborators
Ludwig Institute for Cancer Research
MedImmune LLC
Cancer Research Institute, New York City
Investigators
Study Chair: Jedd Wolchok, MD, PhD MSKCC
  More Information

No publications provided

Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT01975831     History of Changes
Other Study ID Numbers: LUD2013-003
Study First Received: October 29, 2013
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tremelimumab
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014