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: 18.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10071664Term: Bladder transitional cell carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: 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-NL
- Lead Sponsor
- AstraZenenca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
1. Patients affected by histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following:
-UBC
-Metastatic PDAC
-TNBC.
2. Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy
3. Adequate organ and marrow function
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method