Enoblituzumab Schedule 1
Biologicalenoblituzumab is administered by IV infusion once per week for up to 51 doses.
Other names: MGA271
NCT Number: NCT02475213
The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), Urothelial Cancer and other B7-H3 expressing cancers. The study will also evaluate what is the highest dose of enoblituzumab that can be given safely when given with pembrolizumab. Assessments will also be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity of MGA271 in combination with pembrolizumab. Safety and efficacy of enoblituzumab in combination with MGA012 (anti-PD-1 monoclonal antibody; also known as INCMGA00012) will also be evaluated.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Mayo Clinic - AZ, Scottsdale, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
enoblituzumab is administered by IV infusion once per week for up to 51 doses.
Other names: MGA271
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Other names: Keytruda
Enoblituzumab is administered by IV infusion every 3 weeks for up to 17 doses
Other names: MGA271
Retifanlimab is administered by IV infusion every 3 weeks for up to 17 doses
Other names: INCMGA00012, MGA012
Time frame: Study Day 1-42, for Cohorts 1-4.
Dose-limiting toxicities are severe side effects related to study treatment that may cause dose interruptions, dose reductions, or withdrawal of treatment.
Time frame: Baseline, 1, 4, 24, and 72 hours after the first dose.
The highest measured concentration of enoblizuzumab in the bloodstream.
Time frame: At baseline, and Day 7.
Trough concentration is the concentration measured before the a subsequent dose of enoblituzumab.
MGA271 is characterized by a biphasic concentration-time profile and PPK was used to estimate PK parameters at each dose level
Time frame: At baseline, 1, 4, 24, 72 hours, and Day 7.
AUC is the total body exposure to enoblituzumab MGA271 is characterized by a biphasic concentration-time profile and PPK was used to estimate PK parameters at each dose level
Time frame: At baseline, 1, 4, 24, 72 hours, and Day 7.
Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time.
Time frame: At baseline, 1, 4, 24, and 72 and Day 7.
The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream
Time frame: At baseline, 1, 4, 24, and 72 and Day 7.
Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium MGA271 is characterized by a biphasic concentration-time profile and PPK was used to estimate PK parameters at each dose level
Time frame: Every 3 weeks throughout the study, average duration 13 months.
Time frame: Every 3 weeks throughout the study, average duration 13 months.
Time frame: Six weeks after the first dose, then every 9 weeks throughout study until discontinuation, average 13 months
The number of participants with a complete response (CR) or partial response (PR) to enoblituzumab in combination with pembrolizumab or retifanlimab RECIST 1.1 criteria.
Time frame: Six weeks after the first dose, then every 9 weeks throughout study until discontinuation, average 13 months
The number of participants with a complete response (CR) or partial response (PR) to enoblituzumab in combination with pembrolizumab or retifanlimab using irRECIST 1.1 criteria.
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD) or not evaluated (NE)
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD) or not evaluated (NE)
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average13 months.
The duration of response displays the minimum and maximum range in months from the first documented CR or PR until disease progression or death, whichever is first.
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
The duration of response displays the minimum and maximum range in months from the first documented CR or PR until disease progression or death, whichever is first.
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
The time from the first infusion of pembrolizumab or retifanlimab until documented disease progression or death from any cause.
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
The time from the first infusion of pembrolizumab or retifanlimab until documented disease progression or death from any cause.
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
The time from the first infusion of pembrolizumab or retifanlimab until death from any cause.
MacroGenics
Industry
A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination With Pembrolizumab and in Combination With MGA012 in Patients With Melanoma, Squamous Cell Cancer of the Head and Neck, Non-Small Cell Lung Cancer, Urothelial Cancer, and Other Cancers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03511391
Adenocarcinoma, Bronchial Neoplasms
Ghent, Oost-Vlaanderen, Belgium
View Trial DetailsNCT04198766
Adenocarcinoma, Bronchial Neoplasms
Duarte, California, United States
View Trial DetailsNCT03452774
Adenocarcinoma, Adnexal Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT03212404
Adenocarcinoma, Adenoma
Wollongong, New South Wales, Australia
View Trial Details