Clinical trial · Interventional
Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer
A Phase1b/2 Study Assessing Safety and Anti-tumor Activity of AMG 820 in Combination With Pembrolizumab in Select Advanced Solid Tumors
NCT02713529CI-TRIAL-00063370completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in subjects with select advanced solid tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG820 and pembrolizumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AMG820 and pembrolizumab
- description
- Treatment with AMG820 and pembrolizumab
- interventionNames
- Biological: AMG820 and pembrolizumab
Primary outcomes (5)
- measure
- Participants With Dose Limiting Toxicities (DLT)
- timeFrame
- The DLT evaluation period was Day 1 to Day 21
- description
- DLTs were evaluated by the Dose Level Review Team (DLRT). A DLT was defined as any grade \>=3 adverse event occurring during a DLT time window (21 day period from the initial administration of AMG 820 and pembrolizumab in combination), and if judged by the investigator to be related to the administration of AMG 820 and/or pembrolizumab.
- measure
- Participants With Treatment -Emergent Adverse Events (TEAEs)
- timeFrame
- Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically documented, advanced colorectal, pancreatic or non-small cell lung cancer that is refractory to standard treatment, or the subjects have been intolerant to or refuse standard treatment. * Measurable disease per RECIST 1.1 guidelines. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 * Adequate hematologic, renal, and hepatic function determined by laboratory blood and urine tests. * Availability of recent tumor tissue within 3 months prior to enrollment, when feasible. Exclusion Criteria: * Has known active central nervous system metastases and/or carcinomatous meningitis. * History of other malignancy with the past 2 years with some exceptions * Evidence of active non-infectious pneumonitis/interstitial lung disease * Evidence of other active autoimmune disease that has required prolonged systemic treatment in past 2 years. * Evidence of clinically significant immunosuppression such as organ or stem cell transplantation, any severe congenital or acquired cellular and/or humoral immune deficiency, concurrent opportunistic infection. * Receiving systemic immunostimulatory agents within 6 weeks or 5 half-lives, whichever is shorter, prior to first dose of study treatment (except ant PD-1/PD-L1 treatment if recruited into Group 4a or 4b). * Evidence of active infection within 2 weeks prior to first dose of study treatment. * Prior chemotherapy, radiotherapy, biological cancer therapy or major surgery within 28 days prior to enrollment * Currently participating or has participated in a study (treatment period only) of an investigational agent or used an investigational device within 28 days of enrollment * Received live vaccine within 28 days prior to enrollment * Adverse event due to cancer therapy administered more than 28 days prior to enrollment that has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better. * Positive for human immunodeficiency virus (HIV), Hepatitis B or C * Women planning to become pregnant or who are lactating/breastfeeding while on study through 4 months after receiving the last dose of study drug.
References
Publications (1)
- BACKGROUNDRazak AR, Cleary JM, Moreno V, Boyer M, Calvo Aller E, Edenfield W, Tie J, Harvey RD, Rutten A, Shah MA, Olszanski AJ, Jager D, Lakhani N, Ryan DP, Rasmussen E, Juan G, Wong H, Soman N, Smit MD, Nagorsen D, Papadopoulos KP. Safety and efficacy of AMG 820, an anti-colony-stimulating factor 1 receptor antibody, in combination with pembrolizumab in adults with advanced solid tumors. J Immunother Cancer. 2020 Oct;8(2):e001006. doi: 10.1136/jitc-2020-001006. PMID 33046621