Study of Tremelimumab in Patients With Advanced Solid Tumors

NCT02527434 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: D4884C000012015-002934-32
• Study Type: interventional
• Target: 64
• Locations: 5 countries
• Sites: 14

Brief Summary

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors

Conditions

Urothelial Bladder Cancer; Triple-negative Breast Cancer; Pancreatic Ductal Adenocarcinoma

Keywords

Urothelial bladder cancer, Triple-negative breast cancer, Pancreatic ductal adenocarcinoma, Advanced Solid Tumors, Tremelimumab, MEDI4736, ORR

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase

  Objective response rate (ORR) during the initial tremelimumab monotherapy phase was assessed by the site Investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and was defined as the percentage of patients with a confirmed overall response of complete response (CR) or partial response (PR) and was based on all treated patients who had measurable disease at baseline (Day 1). 95% confidence intervals (CIs) were calculated using the Clopper Pearson method.

  From baseline to 12 months in the tremelimumab monotherapy phase

Secondary Outcomes (11)

• Median Duration of Response (DoR) During Tremelimumab Monotherapy Phase

  From baseline to 12 months in the tremelimumab monotherapy phase

• Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase

  From baseline to 12 months in the tremelimumab monotherapy phase

• Median PFS During Tremelimumab Monotherapy Phase

  From baseline to 12 months in the tremelimumab monotherapy phase

• Best Objective Response (BoR) During Tremelimumab Monotherapy Phase

  From baseline to 12 months in the tremelimumab monotherapy phase

• Median Overall Survival (OS) During Tremelimumab Monotherapy Phase

  From baseline to final data cut-off date

Study Arms (1)

treme mono to be sequenced to MEDI4736 mono or combination

EXPERIMENTAL

tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD)

Biological: Tremelimumab monotherapy; Biological: MEDI4736 monotherapy; Biological: MEDI4736 + tremelimumab combination therapy

Interventions

Tremelimumab monotherapy BIOLOGICAL

IV infusion

treme mono to be sequenced to MEDI4736 mono or combination

MEDI4736 monotherapy BIOLOGICAL

IV infusion

treme mono to be sequenced to MEDI4736 mono or combination

MEDI4736 + tremelimumab combination therapy BIOLOGICAL

IV infusion

treme mono to be sequenced to MEDI4736 mono or combination

Eligibility Criteria

• Age: 18 Years - 150 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy; 2. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) (preferred) or magnetic resonance imaging (MRI) scans and that is suitable for accurate repeated measurements.

You may not qualify if:

• \. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer Treatment; 2. History of leptomeningeal carcinomatosis; 3. Active or prior documented autoimmune or inflammatory disorders; 4. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 14 days prior to study treatment start; 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms; 6. Known allergy or hypersensitivity to IP or any IP excipient

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (14)

Research Site

San Francisco, California, 94158, United States

Location

Research Site

Memphis, Tennessee, 38120, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

Brussels, 1090, Belgium

Location

Research Site

Charleroi, 6000, Belgium

Location

Research Site

Wilrijk, 2610, Belgium

Location

Research Site

Groningen, 9713 GZ, Netherlands

Location

Research Site

Utrecht, 3584 CX, Netherlands

Location

Research Site

Gdansk, 80-214, Poland

Location

Research Site

Lodz, 93-513, Poland

Location

Research Site

Daejeon, 35015, South Korea

Location

Research Site

Seoul, 03080, South Korea

Location

Research Site

Seoul, 03722, South Korea

Location

Research Site

Seoul, 135-710, South Korea

Location

Related Links

• Related Info
• Related Info
• Redacted CSR synopsis

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

+1 302 885 1180

Study Officials

• Sharma Padmanee, MD, PhD

  Anderson Cancer Center, the University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 19, 2015
• Study Start: November 2, 2015
• Primary Completion: February 17, 2018
• Study Completion: March 28, 2023
• Last Updated: November 15, 2023
• Results First Posted: March 5, 2019

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

US (3); PL (2); NL (2); KR (4); BE (3)