Phase 2
N=159
M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
Biliary Tract Cancer · Cholangiocarcinoma · Gallbladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03833661 ↗Enrolled (actual)
159
Serious AEs
54.1%
Results posted
Jan 2022
Primary outcome: Primary: Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) — 10.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- M7824 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EMD Serono Research & Development Institute, Inc.
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) |
10.7 | — |
| SECONDARY Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) |
10.0 | — |
| SECONDARY Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) |
6.3 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) |
152; 99; 10; 46; 13; 44 | — |
| SECONDARY Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) |
1.8 | — |
| SECONDARY Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator |
10.7 | — |
| SECONDARY Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator |
8.2 | — |
| SECONDARY Durable Response Rate (DRR) Acoording to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator |
5.7 | — |
| SECONDARY Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator |
1.8 | — |
| SECONDARY Overall Survival (OS) |
7.6 | — |
| SECONDARY Serum Pre-Dose Concentrations (Ctrough) of M7824 |
70.7; 84.2; 93.4; 105; 117; 101 | — |
| SECONDARY Serum Concentration at End of Infusion (CEOI) of M7824 |
399; 434 | — |
| SECONDARY Number of Participants With Positive Antidrug Antibodies (ADA) |
45 | — |
| SECONDARY Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression |
10.2; 7.0; 9.7; 7.1; 8.7; 13.3 | — |
| SECONDARY Percentage of Participants With Confirmed Objective Response as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) According to Microsatellite Instability (MSI) Status |
0.0; 10.0 | — |
| SECONDARY Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression |
NA; 5.8; NA; NA; NA; NA | — |
| SECONDARY Duration of Response (DOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status |
NA | — |
| SECONDARY Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression |
6.1; 2.3; 5.3; 3.6; 4.8; 6.7 | — |
| SECONDARY Durable Response Rate (DRR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by an Independent Review Committee (IRC) According to According to Microsatellite Instability (MSI) Status |
0.0; 4.0 | — |
Summary
The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC.
- Availability of tumor (primary or metastatic) archival material or fresh biopsies is mandatory
- Participants with BTC must have failed or be intolerant to 1L systemic platinum-based chemotherapy administered for locally advanced or metastatic disease. Only one prior treatment line is allowed
- Disease must be measurable with at least 1 unidimensionally measurable lesion by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
- Life expectancy >= 12 weeks as judged by the Investigator
- Adequate hematological function defined by white blood cell (WBC) count >= 3 * 10^9/Litre with absolute neutrophil count (ANC) >= 1.5 * 109/Litre, lymphocyte count >= 0.5 * 10^9/Litre, platelet count >=75 * 10^9/Litre, and hemoglobin (Hgb) >= 9 grams/decilitre
- Adequate hepatic function defined by a total bilirubin level = = 3.0 grams/decilitre
- Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals
- Adequate renal function defined by either creatinine = 40 milliliter (mL) per minute (min) according to the Cockcroft-Gault formula or by measure of CCr from 24-hour urine collection
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- Ampullary cancer was excluded
- Significant acute or chronic infections
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- Interstitial lung disease or its history
- Participants who were not eligible for or have not been treated with 1L systemic chemotherapy
- Anticancer treatment within 21 days before the start of study intervention
- Concurrent treatment with nonpermitted drugs
- Prior participation in a M7824 clinical trial
- Prior therapy with other immunotherapy or checkpoint inhibitors, such as anti-PD 1, anti PD L1, anti- cytotoxic T-cell lymphocyte-4 (CTLA-4) antibodies.
- Pregnancy or breast feeding
- Systemic anticancer treatment after failing 1L platinum-based chemotherapy
- Other protocol defined exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03833661). 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.