Description:
The purpose of this study is to determine the safety, tolerability, and efficacy of
INCAGN01949 when given in combination with immune therapies in participants with advanced or
metastatic malignancies.
Title
- Brief Title: A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies
- Official Title: A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01949 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Clinical Trial IDs
- ORG STUDY ID:
INCAGN 1949-201
- NCT ID:
NCT03241173
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| INCAGN01949 | | INCAGN01949 + Ipilimumab |
| Nivolumab | | INCAGN01949 + Nivolumab |
| Ipilimumab | | INCAGN01949 + Ipilimumab |
| INCAGN01949 | | INCAGN01949 + Nivolumab |
Purpose
The purpose of this study is to determine the safety, tolerability, and efficacy of
INCAGN01949 when given in combination with immune therapies in participants with advanced or
metastatic malignancies.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| INCAGN01949 + Nivolumab | Experimental | INCAGN01949 combined with nivolumab. | |
| INCAGN01949 + Ipilimumab | Experimental | INCAGN01949 combined with ipilimumab. | |
| INCAGN01949 + Nivolumab + Ipilimumab | Experimental | INCAGN01949 combined with nivolumab and ipilimumab. | - Nivolumab
- Ipilimumab
- INCAGN01949
|
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 gastric cancer, SCCHN, NSCLC, or RCC and
are considered refractory to prior PD-1/L1 therapy.
- 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
- 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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Phase 1: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] |
| Time Frame: | Screening through 60 days after end of treatment, up to 18 months |
| Safety Issue: | |
| Description: | TEAEs defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent. |
Secondary Outcome Measures
| Measure: | Phase 1 & Phase 2: ORR based on RECIST v1.1 and modified RECIST (mRECIST) |
| Time Frame: | Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months |
| Safety Issue: | |
| Description: | Defined as the percentage of subjects having a CR or PR. |
| Measure: | Phase 1 & Phase 2: Duration of response based on RECIST v1.1 and mRECIST |
| Time Frame: | Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months |
| Safety Issue: | |
| Description: | Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause, if occurring sooner than progression. |
| Measure: | Phase 1 & Phase 2: Disease control rate based on RECIST v1.1 and mRECIST |
| Time Frame: | Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months |
| Safety Issue: | |
| Description: | Defined as the percentage of subjects having a CR, PR, or stable disease (SD). |
| Measure: | Phase 1 & Phase 2: Duration of disease control based on RECIST v1.1 and mRECIST |
| Time Frame: | Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months |
| Safety Issue: | |
| Description: | Defined as CR, PR, and SD as measured from first report of SD or better until disease progression or death from any cause, if occurring sooner than progression. |
| Measure: | Phase 1 & Phase 2: Progression-free survival based on RECIST v1.1 and mRECIST |
| Time Frame: | Assessed every 8 weeks for 12 months, then every 12 weeks, up to 18 months |
| Safety Issue: | |
| Description: | Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause, if occurring sooner than progression. |
| Measure: | Phase 1 & Phase 2: Overall survival |
| Time Frame: | At 1 year, 2 years, and end of study, up to 24 months |
| Safety Issue: | |
| Description: | Determined from the start of combination therapy until death due to any cause. |
| Measure: | Phase 1 & Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] |
| Time Frame: | Screening through 60 days after end of treatment, up to 18 months |
| Safety Issue: | |
| Description: | TEAEs defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent. |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Incyte Biosciences International Sàrl |
Trial Keywords
- advanced or metastatic cervical cancer
- endometrial cancer
- esophageal cancer
- hepatocellular carcinoma (HCC)
- melanoma
- Merkel cell carcinoma
- mesothelioma
- microsatellite instability-high colorectal cancer
- non-small cell lung cancer (NSCLC)
- ovarian cancer
- squamous cell carcinoma of the head and neck
- small cell lung cancer (SLCL)
- renal cell carcinoma (RCC)
- triple-negative breast cancer
- TNBC
- urothelial carcinoma
- OX40 ligand (OX40)
- SCCHN
- MSI-H CRC
- gastric cancer (including stomach and gastroesophageal junction [GEJ])
Last Updated
September 1, 2020
