A Phase 1/2 Study to Evaluate MEDI4736
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Jacksonville, Florida: 14-007490
NCT ID: NCT01693562
Sponsor Protocol Number: CD-ON-MEDI4736-1108
About this study
This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in subjects with advanced solid tumors followed by an expansion phase in patients with advanced solid tumors. An exploration cohort has been added to determine the safety using Q4W dosing.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- Age 18 or older.
- In the dose-escalation phase: histologically- or cytologically- confirmed advanced solid tumor that is refractory to standard therapy and for which no standard therapy exists.
- In the dose-expansion phase: histologically- or cytologically- confirmed advanced solid tumor where if an approved first-line therapy is available, subjects must have failed, be intolerant to, be ineligible for, or have refused
- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
- Adequate organ and marrow function.
- Subjects must have at least 1 measurable lesion.
- Available archived tumor tissue sample.
- Willingness to provide consent for biopsy sample (dose-expansion only)
- Any prior Grade ≥ 3 irAE while receiving immunotherapy
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
- Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
- Prior treatment with immunotherapy agents including, but not limited to, tumor necrosis factor receptor superfamily agonists or checkpoint inhibitors or natural killer (NK) cell inhibitors.
- Active or prior documented autoimmune disease within the past 2 years
- History of primary immunodeficiency
- History of organ transplant that requires use of immunosuppressives
- Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent treatment
- Other invasive malignancy within 2 years
- Women who are pregnant or lactating
- Uncontrolled intercurrent illness
- Known history of tuberculosis
- Known to be human immunodeficiency virus (HIV) positive
- Known to be Hepatitis B or C positive (except HCC patients)
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Gerardo Colon-Otero, M.D.
Closed for enrollment
Cancer Center Clinical Trials Referral Office
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available