Locally Advanced or Metastatic Solid Tumors Clinical Trial
Official title:
A Phase 1b, Open-Label, Dose Escalation and Expansion Study of Demcizumab Plus Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
NCT number | NCT02722954 |
Other study ID # | M18-008 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | May 19, 2017 |
Verified date | August 2020 |
Source | Mereo BioPharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to test the efficacy and safety of an experimental drug,
demcizumab, when given in combination with pembrolizumab. Demcizumab is a humanized
monoclonal antibody and was developed to target cancer stem cells. Demcizumab may block the
growth of cancer stem cells, the remaining cancer cells, and it may also impair the
productive growth of new blood vessels, which tumors need to grow and spread.
This study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the
Sponsor in this consent form.
Status | Completed |
Enrollment | 29 |
Est. completion date | May 19, 2017 |
Est. primary completion date | May 10, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: 1. Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1 2. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue, either fresh core-needle-biopsied or archived 3. Age >21 years 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Adequate organ and marrow function 6. For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit. 7. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy, or herbal therapy within 3 weeks or 5 half-lives (for systemic agents) whichever is shorter 2. Receiving any other investigational agents or any other anti-cancer therapy 3. Active infections requiring antibiotics 4. Patients with brain metastases (treated or untreated) leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease 5. History of interstitial lung disease or active, non-infectious pneumonitis that required oral or intravenous corticosteroids 6. Prior radiation to the chest wall or mediastinum if the radiation field involves the heart 7. Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months 8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study 9. Pregnant or nursing women 10. New York Heart Association Classification II, III, or IV 11. Acute prior study treatment related toxicity (except alopecia) that has not resolved to Grade < or = to 1 unless it has been deemed stable by the investigator 12. Inability to comply with study and follow up procedure |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Royal Marsden NHS Foundation Trust | Sutton | Surrey |
United States | University of Michigan Health System | Ann Arbor | Michigan |
United States | Rocky Mountain Cancer Center | Denver | Colorado |
United States | Sarah Cannon Research Institute | Nashville | Tennessee |
United States | Columbia University Medical Center | New York | New York |
United States | The START Center for Cancer Care | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
OncoMed Pharmaceuticals, Inc. | Celgene Corporation |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose limiting toxicities (DLT) of demcizumab given in combination with pembrolizumab | The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with demcizumab in combination with pembrolizumab | Subjects will be treated and observed for DLT through the end of the first cycle (Days 1-22) | |
Secondary | Pharmacokinetics (PK) of demcizumab and pembrolizumab | peak plasma concentration | Plasma sample for Pharmacokinetics (PK) analysis to be obtained on Days 1, 22, 43 then at every other cycle (each cycle is 21 days) until 12 weeks post treatment termination, an average of 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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