A Study to Evaluate MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors

NCT02705482 | Completed Phase 1 FDA Drug

• 1 other identifier: D6060C00002
• Study Type: interventional
• Target: 58
• Locations: 3 countries
• Sites: 12

Brief Summary

The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.

Conditions

Select Advanced Solid Tumors

Keywords

Advanced solid tumors; MEDI0562; durvalumab; tremelimumab; OX40; PD-L1; CTLA-4; immuno-oncology; Cancer

Outcome Measures

Primary Outcomes (1)

• Safety as defined by the presence of adverse events (AE), serious adverse events (SAE), and dose limiting toxicities (DLT).

  The primary endpoint is safety as assessed by presence of adverse event (AE), serious adverse event (SAE), and dose limiting toxicity (DLT).

  From time of informed consent through 12 weeks after ending treatment with investigational product

Secondary Outcomes (14)

• Preliminary Antitumor Activity:Best Overall Response

  At approximately 3 time points through Day 113.

• Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: Cmax

  To be assessed at approximately 12 clinic visits through Day 113

• Immunogenicity

  At approximately 8 time points through Day 113.

• Pharmacodynamic Activity

  At approximately 12 time points through Day 113.

• Preliminary Antitumor Activity: Disease Control

  At approximately 3 time points through Day 113.

Study Arms (2)

Arm A: MEDI0562 and durvalumab

EXPERIMENTAL

MEDI0562 and durvalumab

Biological: MEDI0562; Biological: Durvalumab

Arm B: MEDI0562 and tremelimumab

EXPERIMENTAL

MEDI0562 and tremelimumab

Biological: MEDI0562; Biological: Tremelimumab

Interventions

MEDI0562 BIOLOGICAL

Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.

Arm A: MEDI0562 and durvalumab; Arm B: MEDI0562 and tremelimumab

Tremelimumab BIOLOGICAL

Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.

Arm B: MEDI0562 and tremelimumab

Durvalumab BIOLOGICAL

Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.

Arm A: MEDI0562 and durvalumab

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria:
• Written and signed informed consent.
• Age ≥ 18 years at the time of study entry.
• Subjects must have received and have progressed, are refractory, or are intolerant to standard therapy appropriate for the specific tumor type. Subjects should not have received more than 3 prior lines of systemic therapy for recurrent or metastatic.
• Subjects in the dose-escalation phase, must have histologic documentation of advanced solid tumors, excluding primary CNS tumors and hematologic malignancies.
• Subjects in the dose-expansion phase, must have recurrent or metastatic disease solid tumors according to treatment arm as specified in the protocol.
• Subjects who have received prior therapy with regimens containing CTLA 4, PD L1, or PD 1 antagonists are permitted to enroll if additional protocol criteria are met.
• Subjects must have at least 1 lesion that is measurable using RECIST guidelines.
• Subjects must consent to provide archived tumor specimens for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, subjects must consent and undergo fresh tumor biopsy.
• All subjects are encouraged to consent to and provide both pretreatment and on treatment tumor biopsies.
• ECOG Performance score of 0 or 1, unless protocol exceptions are met.
• In the opinion of the investigator likely to complete ≥ 8 weeks of treatment.
• Adequate hematologic, renal and hepatic function as determined by blood laboratory values.
• At the time of Day 1 of the study, subjects with CNS metastases must have been treated and must be asymptomatic and meet the following:
• No concurrent treatment, inclusive of, but not limited to surgery, radiation, and/or corticosteroids

You may not qualify if:

• Any of the following would exclude the subject from participation in the study:
• Prior treatment with TNFRSF agonists
• Prior treatment with IMT for certain disease types may be restricted per protocol.
• History of severe allergic reactions to any unknown allergens or any components of the study drug formulations
• Active or prior documented autoimmune disease within the past 2 years.
• Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow up period of an interventional study
• Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days prior to the first dose
• Any concurrent chemotherapy, IMT, or biologic or hormonal therapy for cancer treatment.
• Unresolved toxicities from prior anticancer therapy.
• Systemic therapeutic anticoagulation or daily aspirin dose exceeding 325 mg/per day.
• Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI0562 with exceptions as per protocol.
• History of primary immunodeficiency, solid organ transplantation, or tuberculosis
• Test results indicating active infection with human immunodeficiency virus (HIV) or hepatitis B or C defined by positive serologic testing and confirmatory viral nucleic acid testing
• Pregnant or breastfeeding women
• Major surgery within 4 weeks prior to first dose of MEDI0562 or still recovering from prior surgery.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (12)

Research Site

Santa Monica, California, 90404, United States

Location

Research Site

Chicago, Illinois, 60611, United States

Location

Research Site

St Louis, Missouri, 63110, United States

Location

Research Site

Albuquerque, New Mexico, 87106, United States

Location

Research Site

New York, New York, 10032, United States

Location

Research Site

Huntersville, North Carolina, 28078, United States

Location

Research Site

Portland, Oregon, 97213, United States

Location

Research Site

Nashville, Tennessee, 37203, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

Villejuif, 94805, France

Location

Research Site

Amsterdam, 1066 CX, Netherlands

Location

Research Site

Amsterdam, 1081 HV, Netherlands

Location

Related Publications (1)

• Goldman JW, Piha-Paul SA, Curti B, Pedersen KS, Bauer TM, Groenland SL, Carvajal RD, Chhaya V, Kirby G, McGlinchey K, Hammond SA, Streicher K, Townsley DM, Chae YK, Voortman J, Marabelle A, Powderly J. Safety and Tolerability of MEDI0562, an OX40 Agonist mAb, in Combination with Durvalumab or Tremelimumab in Adult Patients with Advanced Solid Tumors. Clin Cancer Res. 2022 Sep 1;28(17):3709-3719. doi: 10.1158/1078-0432.CCR-21-3016.

  PMID: 35699623 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Insulin-Dependent, 12; Neoplasms

Interventions

tremelimumab; durvalumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: March 10, 2016
• Study Start: March 30, 2016
• Primary Completion: August 7, 2019
• Study Completion: August 7, 2019
• Last Updated: August 26, 2019

Record last verified: 2019-08

Locations

NL (2); US (9); FR (1)