MelanomaPhase 1NCT02475213
Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer
A Phase 1 study testing Enoblituzumab Schedule 1, Pembrolizumab and Enoblituzumab Schedule 2 in people with Melanoma and Head and Neck Cancer, run by MacroGenics at 20 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Head and Neck Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Enoblituzumab Schedule 1, Pembrolizumab and Enoblituzumab Schedule 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 20 sitesUnited States
- Study dates
- Jul 2015to 18 Aug 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To enroll on cohorts 1-4, participants must have a histologically-proven, previously treated, unresectable, locally advanced or metastatic mesothelioma, urothelial cancer, thyroid cancer, pancreatic cancer, ovarian cancer, colon cancer, prostate cancer, soft tissue sarcoma, triple negative breast cancer, renal clear cell cancer, melanoma, squamous cell cancer of the head and neck, or non-small cell lung cancer.
- Participants on the melanoma cohort must have progressed on or after at least one anti-PD-L1 or anti- PD-1 containing therapy.
- Participants on the SCCHN cohort must have progressed on or after platinum-based systemic therapy
- Participants on the NSCLC cohort must have progressed on or after first line systemic therapy
- Participants on the urothelial cancer cohort must have received at least one platinum-containing regimen and have progressed on or after an anti-PD-L1 or anti-PD-1 containing therapy
- Measurable disease per RECIST 1.1 criteria
- Easter Cooperative Oncology Group (ECOG) performance status 0 or 1
- Acceptable laboratory parameters and adequate organ reserve.
Who cannot join
- Patients with a history of symptomatic central nervous system metastases, unless treated and asymptomatic
- Patients with history of autoimmune disease with certain exceptions such as vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic therapy within the past 2 years, patients with history of Grave's disease that are now euthyroid clinically and by lab testing
- History of allogeneic bone marrow, stem cell, or solid organ transplant
- Treatment with systemic cancer therapy or investigational therapy within 4 weeks of first study drug administration; radiation within 2 weeks; corticosteroids (greater than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive drugs within 2 weeks of first study drug administration
- Trauma or major surgery within 4 weeks of first study drug administration
- History of clinically-significant cardiovascular disease; gastrointestinal perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4 weeks of first study drug administration
Show all 10Show fewer
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days of first study drug administration
- Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction (PCR)
- Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome
- Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the drug or vehicle formulation for MGA271 or pembrolizumab.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, 21201
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Gabrail Cancer Institute
Canton, Ohio, 44718
Mary Crowley Cancer Research Center
Dallas, Texas, 75230
South Texas Accelerated Research Therapeutics, LLC - Midwest
Grand Rapids, Michigan, 49503
Greenville Health System
Greenville, South Carolina, 29605
Mayo Clinic - FL
Jacksonville, Florida, 32224
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Norton Cancer Institute Research Program
Louisville, Kentucky, 40202
Columbia University Medical Center
New York, New York, 10032
Christiana Care Health Services, Inc.
Newark, Delaware, 19713
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Hospital of the University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
University of Pittsburg
Pittsburgh, Pennsylvania, 15232
Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic - MN
Rochester, Minnesota, 55905
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
Mayo Clinic - AZ
Scottsdale, Arizona, 85259
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: 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
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.
- Being tested
- Enoblituzumab Schedule 1, Pembrolizumab, Enoblituzumab Schedule 2, retifanlimab
- Medical subject headings
- Melanoma, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoblituzumab Schedule 1Biological
Also called MGA271
enoblituzumab is administered by IV infusion once per week for up to 51 doses.
PembrolizumabBiological
Also called Keytruda
Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
Enoblituzumab Schedule 2Biological
Also called MGA271
Enoblituzumab is administered by IV infusion every 3 weeks for up to 17 doses
retifanlimabBiological
Also called INCMGA00012, MGA012
Retifanlimab is administered by IV infusion every 3 weeks for up to 17 doses
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Enoblituzumab 3 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks Receives: Biological: Enoblituzumab Schedule 1; Biological: Pembrolizumab |
| Cohort 2 | Experimental | Enoblituzumab 10 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks Receives: Biological: Enoblituzumab Schedule 1; Biological: Pembrolizumab |
| Cohort 3 | Experimental | Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks Receives: Biological: Enoblituzumab Schedule 1; Biological: Pembrolizumab |
| Cohort 4 | Experimental | Enoblituzumab 15 mg/kg IV plus retifanlimab 375 mg IV every 3 weeks Receives: Biological: Enoblituzumab Schedule 2; Biological: retifanlimab |
| Melanoma Cohort | Experimental | Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks Receives: Biological: Enoblituzumab Schedule 1; Biological: Pembrolizumab |
| Urothelial Cancer Cohort | Experimental | Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks Receives: Biological: Enoblituzumab Schedule 1; Biological: Pembrolizumab |
| Non-small Cell Cancer (NSCLC) Cohort | Experimental | Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks Receives: Biological: Enoblituzumab Schedule 1; Biological: Pembrolizumab |
| Squamous Cell Cancer of Head and Neck (SCCHN) Cohort | Experimental | Enoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks Receives: Biological: Enoblituzumab Schedule 1; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-limiting Toxicities (DLT) After Administration of Enoblituzumab and Pembrolizumab or Retifanlimab
Dose-limiting toxicities are severe side effects related to study treatment that may cause dose interruptions, dose reductions, or withdrawal of treatment.
Measured: Study Day 1-42, for Cohorts 1-4.
Secondary outcomes (17)
Mean Maximum Concentration of Enoblituzumab
The highest measured concentration of enoblizuzumab in the bloodstream.
Measured: Baseline, 1, 4, 24, and 72 hours after the first dose.
Mean Trough Concentration of Enoblituzumab
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
Measured: At baseline, and Day 7.
Mean Area Under the Concentration Time Curve (AUC) From Time 0 to Day 7 of Enoblituzumab
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
Measured: At baseline, 1, 4, 24, 72 hours, and Day 7.
Mean Clearance of Enoblituzumab
Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time.
Measured: At baseline, 1, 4, 24, 72 hours, and Day 7.
Mean Volume of Distribution at Steady State of Enoblituzumab in Combination With Pembrolizumab or Retifanlimab
The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream
Measured: At baseline, 1, 4, 24, and 72 and Day 7.
Mean Terminal Half-life of Enoblituzumab in Combination With Pembrolizumab or Retifanlimab
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
Measured: At baseline, 1, 4, 24, and 72 and Day 7.
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA)
Measured: Every 3 weeks throughout the study, average duration 13 months.
Number of Participants That Develop Retifanlimab ADA
Measured: Every 3 weeks throughout the study, average duration 13 months.
Objective Response Rate
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.
Measured: Six weeks after the first dose, then every 9 weeks throughout study until discontinuation, average 13 months
ORR Using Immune-related (ir) RECIST Criteria
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.
Measured: Six weeks after the first dose, then every 9 weeks throughout study until discontinuation, average 13 months
Best Overall Response (RECIST 1.1)
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)
Measured: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Best Overall Response (irRECIST 1.1)
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)
Measured: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Minimum and Maximum Duration of Response (DoR) Per irRECIST 1.1
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.
Measured: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average13 months.
Minimum and Maximum DoR Per RECIST 1.1
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.
Measured: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Median Progression-free Survival (PFS) Using RECIST 1.1
The time from the first infusion of pembrolizumab or retifanlimab until documented disease progression or death from any cause.
Measured: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Median PFS Using irRECIST 1.1 Criteria
The time from the first infusion of pembrolizumab or retifanlimab until documented disease progression or death from any cause.
Measured: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Median Overall Survival
The time from the first infusion of pembrolizumab or retifanlimab until death from any cause.
Measured: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley Ward, MD, Study director, MacroGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475213
- Sponsor's protocol ID
- CP-MGA271-03
- Status last verified
- Aug 2025
- First submitted
- 16 Jun 2015
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aggarwal C, Prawira A, Antonia S, Rahma O, Tolcher A, Cohen RB, Lou Y, Hauke R, Vogelzang N, P Zandberg D, Kalebasty AR, Atkinson V, Adjei AA, Seetharam M, Birnbaum A, Weickhardt A, Ganju V, Joshua AM, Cavallo R, Peng L, Zhang X, Kaul S, Baughman J, Bonvini E, Moore PA, Goldberg SM, Arnaldez FI, Ferris RL, Lakhani NJ. Dual checkpoint targeting of B7-H3 and PD-1 with enoblituzumab and pembrolizumab in advanced solid tumors: interim results from a multicenter phase I/II trial. J Immunother Cancer. 2022 Apr;10(4):e004424. doi: 10.1136/jitc-2021-004424.
PubMed 35414591
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02475213
- Acronym / sponsor ID
- CP-MGA271-03
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Posted 11 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: Enoblituzumab Schedule 1, Biological: PembrolizumabEnoblituzumab 3 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| Cohort 2 | Experimental | Biological: Enoblituzumab Schedule 1, Biological: PembrolizumabEnoblituzumab 10 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| Cohort 3 | Experimental | Biological: Enoblituzumab Schedule 1, Biological: PembrolizumabEnoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| Cohort 4 | Experimental | Biological: Enoblituzumab Schedule 2, Biological: retifanlimabEnoblituzumab 15 mg/kg IV plus retifanlimab 375 mg IV every 3 weeks |
| Melanoma Cohort | Experimental | Biological: Enoblituzumab Schedule 1, Biological: PembrolizumabEnoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| Urothelial Cancer Cohort | Experimental | Biological: Enoblituzumab Schedule 1, Biological: PembrolizumabEnoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| Non-small Cell Cancer (NSCLC) Cohort | Experimental | Biological: Enoblituzumab Schedule 1, Biological: PembrolizumabEnoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
| Squamous Cell Cancer of Head and Neck (SCCHN) Cohort | Experimental | Biological: Enoblituzumab Schedule 1, Biological: PembrolizumabEnoblituzumab 15 mg/kg IV weekly plus pembrolizumab 2 mg/kg IV every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- To enroll on cohorts 1-4, participants must have a histologically-proven, previously treated, unresectable, locally advanced or metastatic mesothelioma, urothelial cancer, thyroid cancer, pancreatic cancer, ovarian cancer, colon cancer, prostate cancer, soft tissue sarcoma, triple negative breast cancer, renal clear cell cancer, melanoma, squamous cell cancer of the head and neck, or non-small cell lung cancer.
- Participants on the melanoma cohort must have progressed on or after at least one anti-PD-L1 or anti- PD-1 containing therapy.
- Participants on the SCCHN cohort must have progressed on or after platinum-based systemic therapy
- Participants on the NSCLC cohort must have progressed on or after first line systemic therapy
- Participants on the urothelial cancer cohort must have received at least one platinum-containing regimen and have progressed on or after an anti-PD-L1 or anti-PD-1 containing therapy
Key exclusion criteria (10 listed)
- Patients with a history of symptomatic central nervous system metastases, unless treated and asymptomatic
- Patients with history of autoimmune disease with certain exceptions such as vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic therapy within the past 2 years, patients with history of Grave's disease that are now euthyroid clinically and by lab testing
- History of allogeneic bone marrow, stem cell, or solid organ transplant
- Treatment with systemic cancer therapy or investigational therapy within 4 weeks of first study drug administration; radiation within 2 weeks; corticosteroids (greater than or equal to 10 mg prednisone or equivalent per day) or other immune suppressive drugs within 2 weeks of first study drug administration
- Trauma or major surgery within 4 weeks of first study drug administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoblituzumab Schedule 1Also: MGA271enoblituzumab is administered by IV infusion once per week for up to 51 doses. | Biological | Cohort 1, Cohort 2, Cohort 3, Melanoma Cohort, Non-small Cell Cancer (NSCLC) Cohort, Squamous Cell Cancer of Head and Neck (SCCHN) Cohort, Urothelial Cancer Cohort |
| PembrolizumabAlso: KeytrudaPembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses. | Biological | Cohort 1, Cohort 2, Cohort 3, Melanoma Cohort, Non-small Cell Cancer (NSCLC) Cohort, Squamous Cell Cancer of Head and Neck (SCCHN) Cohort, Urothelial Cancer Cohort |
| Enoblituzumab Schedule 2Also: MGA271Enoblituzumab is administered by IV infusion every 3 weeks for up to 17 doses | Biological | Cohort 4 |
| retifanlimabAlso: INCMGA00012, MGA012Retifanlimab is administered by IV infusion every 3 weeks for up to 17 doses | Biological | Cohort 4 |
Primary outcome
Number of Participants With Dose-limiting Toxicities (DLT) After Administration of Enoblituzumab and Pembrolizumab or Retifanlimab
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.
17 secondary outcomes
Mean Maximum Concentration of Enoblituzumab
Time frame: Baseline, 1, 4, 24, and 72 hours after the first dose.
Mean Trough Concentration of Enoblituzumab
Time frame: At baseline, and Day 7.
Mean Area Under the Concentration Time Curve (AUC) From Time 0 to Day 7 of Enoblituzumab
Time frame: At baseline, 1, 4, 24, 72 hours, and Day 7.
Mean Clearance of Enoblituzumab
Time frame: At baseline, 1, 4, 24, 72 hours, and Day 7.
Mean Volume of Distribution at Steady State of Enoblituzumab in Combination With Pembrolizumab or Retifanlimab
Time frame: At baseline, 1, 4, 24, and 72 and Day 7.
Mean Terminal Half-life of Enoblituzumab in Combination With Pembrolizumab or Retifanlimab
Time frame: At baseline, 1, 4, 24, and 72 and Day 7.
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA)
Time frame: Every 3 weeks throughout the study, average duration 13 months.
Number of Participants That Develop Retifanlimab ADA
Time frame: Every 3 weeks throughout the study, average duration 13 months.
Objective Response Rate
Time frame: Six weeks after the first dose, then every 9 weeks throughout study until discontinuation, average 13 months
ORR Using Immune-related (ir) RECIST Criteria
Time frame: Six weeks after the first dose, then every 9 weeks throughout study until discontinuation, average 13 months
Best Overall Response (RECIST 1.1)
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Best Overall Response (irRECIST 1.1)
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Minimum and Maximum Duration of Response (DoR) Per irRECIST 1.1
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average13 months.
Minimum and Maximum DoR Per RECIST 1.1
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Median Progression-free Survival (PFS) Using RECIST 1.1
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Median PFS Using irRECIST 1.1 Criteria
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Median Overall Survival
Time frame: Evaluated at 6 weeks then every 9 weeks throughout the study until discontinuation, average 13 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35414591Aggarwal C, Prawira A, Antonia S, Rahma O, Tolcher A, Cohen RB, Lou Y, Hauke R, Vogelzang N, P Zandberg D, Kalebasty AR, Atkinson V, Adjei AA, Seetharam M, Birnbaum A, Weickhardt A, Ganju V, Joshua AM, Cavallo R, Peng L, Zhang X, Kaul S, Baughman J, Bonvini E, Moore PA, Goldberg SM, Arnaldez FI, Ferris RL, Lakhani NJ. Dual checkpoint targeting of B7-H3 and PD-1 with enoblituzumab and pembrolizumab in advanced solid tumors: interim results from a multicenter phase I/II trial. J Immunother Cancer. 2022 Apr;10(4):e004424. doi: 10.1136/jitc-2021-004424.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Ward, MD study director
MacroGenics
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Enoblituzumab Schedule 1, Pembrolizumab and Enoblituzumab Schedule 2 in people with Melanoma and Head and Neck Cancer, run by MacroGenics at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-limiting Toxicities (DLT) After Administration of Enoblituzumab and Pembrolizumab or Retifanlimab (time frame: Study Day 1-42, for Cohorts 1-4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02475213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.