Mode
Text Size
Log in / Sign up
Phase 1 Completed N=146 Treatment

Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer

Melanoma · Head and Neck Cancer · Non Small Cell Lung Cancer · Urothelial Carcinoma
Source: ClinicalTrials.gov NCT02475213 ↗
Enrolled (actual)
146
Serious AEs
35.2%
Results posted
Aug 2025
Primary outcomePrimary: Number of Participants With Dose-limiting Toxicities (DLT) After Administration of Enoblituzumab and Pembrolizumab or Retifanlimab — 1; 0; 0; 0 Participants

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 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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Dose-limiting Toxicities (DLT) After Administration of Enoblituzumab and Pembrolizumab or Retifanlimab
1; 0; 0; 0
SECONDARY
Mean Maximum Concentration of Enoblituzumab
223.5; 860.0; 995.4; 580.2
SECONDARY
Mean Trough Concentration of Enoblituzumab
146.2; 551.0; 607.3; 180.2
SECONDARY
Mean Area Under the Concentration Time Curve (AUC) From Time 0 to Day 7 of Enoblituzumab
1207; 4540; 5175; 5919
SECONDARY
Mean Clearance of Enoblituzumab
0.155; 0.154; 0.235; 0.210
SECONDARY
Mean Volume of Distribution at Steady State of Enoblituzumab in Combination With Pembrolizumab or Retifanlimab
6.053; 4.340; 5.814; 6.299
SECONDARY
Mean Terminal Half-life of Enoblituzumab in Combination With Pembrolizumab or Retifanlimab
29.22; 23.27; 20.05; 26.63
SECONDARY
Number of Participants That Develop Enoblituzumab Anti-drug Antibodies (ADA)
3; 3; 99; 10; 1; 0
SECONDARY
Number of Participants That Develop Retifanlimab ADA
11; 0
SECONDARY
Objective Response Rate
0; 33.3; 0; 6.7; 5.9; 33.3
SECONDARY
ORR Using Immune-related (ir) RECIST Criteria
0; 33.3; 0; 6.7; 5.9; 33.3
SECONDARY
Best Overall Response (RECIST 1.1)
0; 0; 0; 0; 0; 0
SECONDARY
Best Overall Response (irRECIST 1.1)
0; 0; 0; 0; 0; 0
SECONDARY
Minimum and Maximum Duration of Response (DoR) Per irRECIST 1.1
NA; 25.95; NA; 6.14; 28.89; 3.48
SECONDARY
Minimum and Maximum DoR Per RECIST 1.1
NA; 25.95; NA; 6.14; 25.89; 3.48
SECONDARY
Median Progression-free Survival (PFS) Using RECIST 1.1
NA; 1.4; 3.6; 2.0; 2.2; 5.1
SECONDARY
Median PFS Using irRECIST 1.1 Criteria
NA; 1.4; 3.6; 2.0; 2.2; 5.1
SECONDARY
Median Overall Survival
18.0; 10.3; 6.3; 14.4; 5.7; 10.3

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02475213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search