A study to see if experimental anti-cancer medicines Tremelimumab, or MEDI4736 or their combination can keep cancer from growing and the safety of these drugs.
- Conditions
- Adult patients (age =18 years) with advanced and metastatic solid tumors including but not limited to histologically or cytologically documented UBC, PDAC, or TNBC.MedDRA version: 21.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10071664Term: Bladder transitional cell carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002934-32-BE
- Lead Sponsor
- AstraZenenca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
1. Age =18 years at the time of screening
2. Written informed consent and any locally required authorization
3. Patients affected by 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 for UBC, Metastatic PDAC or TNBC
4. Willing to give valid written consent to provide a tumor biopsy,
archival or fresh
(preferred), for the purpose of establishing PD-L1 status and for exploratory
biomarker analyses
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. 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, preferably with IV contrast, and that is suitable for
accurate repeated measurements as per RECIST 1.1 guidelines. Lesions in a previously irradiated field can be used as measurable disease provided that there has
been demonstrated progression in the lesion.
7.No prior exposure to immune-mediated therapy, including but not limited to other
anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer vaccines.
8. Adequate organ and marrow function
9. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for
female pre-menopausal patients.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
1. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
2. Receipt of any investigational anticancer therapy within 28 days or 5 half-lives
3. Receipt of last dose of an approved (marketed) anticancer therapy within 21 days prior to the first dose of study treatment.
4. Current or prior use of immunosuppressive medication within 14 days before the first dose of therapy.
5. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment.
6. History of active primary immunodeficiency
7. Known allergy or hypersensitivity to IP or any IP excipient
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Objective response rate (ORR) of tremelimumab monotherapy;Secondary Objective: 1. To further assess the efficacy of tremelimumab monotherapy.<br>2. To assess the efficacy of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination therapy.;Primary end point(s): objective response rate;Timepoint(s) of evaluation of this end point: up to 3 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Duration of response <br>2. Disease control rate <br>3. Progression-free survival <br>4. Overall survival <br>5. Best objective response;Timepoint(s) of evaluation of this end point: up to 3 years