Phase 2
Completed N=51
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
Advanced Malignancies · Metastatic cancer
Source: ClinicalTrials.gov NCT03126110 ↗
Enrolled (actual)
51
Serious AEs
46.9%
Results posted
Dec 2022
Primary outcomePrimary: Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) — 4; 4; 5; 4 Participants
Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
4; 4; 5; 4; 5; 4 | — |
| PRIMARY Phase 2: Objective Response Rate (ORR) Per RECIST v1.1 |
0.0; 0.0; 23.9; 16.7; 0.0; 0.0 | — |
| SECONDARY Phase 1: ORR Per RECIST v1.1 |
25.0; 0.0; 20.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Phase 1: ORR Per Modified RECIST (mRECIST) v1.1 |
25.0; 0.0; 20.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Phase 2: ORR Per mRECIST v1.1 |
0.0; 0.0; 26.1; 16.7; 0.0; 0.0 | — |
| SECONDARY Phase 1: Duration of Response (DOR) Per RECIST v1.1 |
NA; 573.0; 876.0; NA; 281.0 | — |
| SECONDARY Phase 2: DOR Per RECIST v1.1 |
NA; 120.0 | — |
| SECONDARY Phase 1: DOR Per mRECIST v1.1 |
NA; NA; 876.0; NA; NA | — |
| SECONDARY Phase 2: DOR Per mRECIST v1.1 |
NA; NA | — |
| SECONDARY Phase 1: Disease Control Rate (DCR) Per RECIST v1.1 |
25.0; 50.0; 20.0; 50.0; 0.0; 25.0 | — |
| SECONDARY Phase 2: DCR Per RECIST v1.1 |
37.5; 56.3; 54.3; 55.6; 50.0; 50.0 | — |
| SECONDARY Phase 1: DCR Per mRECIST v1.1 |
25.0; 50.0; 20.0; 50.0; 0.0; 25.0 | — |
| SECONDARY Phase 2: DCR Per mRECIST v1.1 |
37.5; 56.3; 56.5; 55.6; 50.0; 50.0 | — |
| SECONDARY Phase 1: Duration of Disease Control Per RECIST v1.1 |
NA; NA; 624.0; 76.0; 167.0; 668.5 | — |
| SECONDARY Phase 2: Duration of Disease Control Per RECIST v1.1 |
218.0; 109.0; 253.0; 168.0; 206.5; 109.0 | — |
| SECONDARY Phase 1: Duration of Disease Control Per mRECIST v1.1 |
NA; NA; NA; 76.0; NA; 668.5 | — |
| SECONDARY Phase 2: Duration of Disease Control Per mRECIST v1.1 |
218.0; 168.0; NA; NA; NA; NA | — |
| SECONDARY Phase 1: Progression-free Survival (PFS) Per RECIST v1.1 |
52.5; 72.0; 53.0; 64.0; 47.5; 60.0 | — |
| SECONDARY Phase 2: PFS Per RECIST v1.1 |
57.0; 75.0; 115.0; 102.0; 87.0; 64.5 | — |
| SECONDARY Phase 1: PFS Per mRECIST v1.1 |
66.0; NA; 116.0; 88.0; 57.0; NA | — |
| SECONDARY Phase 2: PFS Per mRECIST v1.1 |
85.0; 105.0; 235.0; 168.0; 118.0; NA | — |
| SECONDARY Phase 1: Overall Survival |
NA; NA; 253.0; 100.0; 289.5; 266.5 | — |
| SECONDARY Phase 2: Overall Survival |
290.5; 179.0; 491.0; 492.0; 485.0; 264.0 | — |
| SECONDARY Phase 2: : Number of Participants With Any TEAE |
8.; 16; 45; 18; 4; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Phase 1: Subjects with advanced or metastatic solid tumors.
- Phase 1: Subjects who have disease progression after treatment with available therapies.
- Phase 2: Subjects with advanced or metastatic cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN, PD-1 refractory SCCHN and PD-1/PD-L1 relapsed melanoma.
- Presence of measurable disease based on RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Exclusion Criteria
- Laboratory and medical history parameters not within the Protocol-defined range
- Prior treatment with any tumor necrosis factor super family agonist.
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy.
- Active autoimmune disease.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
- Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
Data sourced from ClinicalTrials.gov (NCT03126110). 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.