Phase 2
Completed N=117
Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer
Source: ClinicalTrials.gov NCT02713529 ↗Enrolled (actual)
117
Serious AEs
69.0%
Results posted
Jun 2020
Primary outcomePrimary: Participants With Dose Limiting Toxicities (DLT) — 0; 1; 3; 2 Participants
Summary
A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in subjects with select advanced solid tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Dose Limiting Toxicities (DLT) |
0; 1; 3; 2; 0; 1 | — |
| PRIMARY Participants With Treatment -Emergent Adverse Events (TEAEs) |
8; 7; 41; 31; 4; 19 | — |
| PRIMARY Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment |
5; 7; 41; 25; 4; 14 | — |
| PRIMARY Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment |
5; 7; 39; 24; 4; 13 | — |
| PRIMARY Objective Response Rate (ORR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) |
0.0; 4.9; 0.0; 0.0; 5.3; 0.0 | — |
| SECONDARY Time to Response (TTR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) For Participants Who Responded |
2.1587; 2.0698 | — |
| SECONDARY Time to Progression (TTP) for Participants Who Had Progressive Disease |
2.1865; 3.0691; 2.3878; 4.6762; 6.0863; 7.7864 | — |
| SECONDARY Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 |
59.077; 53.915; 16.705; 75.000; 52.105; 41.667 | — |
| SECONDARY Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 |
10.476; 13.490; 0.000; 25.000; 26.471; 33.333 | — |
| SECONDARY AMG 820 Pharmacokinetic Parameter by Dose Group: Time of Maximum Observed Concentration (Tmax) During Treatment Cycles 1 + 2 |
2.0; 2.0; 3.00; 2.00 | — |
| SECONDARY AMG 820 Pharmacokinetic Parameter by Dose Group: Maximum Observed Drug Concentration (Cmax) During Treatment Cycles 1 + 2 |
331; 485; 363; 536 | — |
| SECONDARY AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Last (AUClast) During Treatment Cycles 1 + 2 |
55100; 80400; 55200; 73500 | — |
| SECONDARY AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Over the Dose Interval (AUCtau) During Treatment Cycles 1 + 2 |
59300; 90000; 75400; 114000 | — |
| SECONDARY AMG 820 Pharmacokinetic Parameter by Dose Group: Minimum Observed Drug Concentration (Cmin) During Treatment Cycles 1 + 2 |
49.9; 90.9; 78.7; 199 | — |
| SECONDARY AMG 820 Pharmacokinetic Parameter by Dose Group: Terminal Elimination Half-life (t1/2z) During Treatment Cycles 1 + 2 |
217; 214; 170 | — |
| SECONDARY AMG 820 Pharmacokinetic Parameter by Dose Group: Volume of Distribution (Vz) During Treatment Cycles 1 + 2 |
5200; 4110; 4560 | — |
| SECONDARY AMG 820 Pharmacokinetic Parameter by Dose Group: Drug Clearance (CL) During Treatment Cycles 1 + 2 |
16.6; 13.3; 18.6 | — |
| SECONDARY AMG 820 Pharmacokinetic Parameter by Dose Group: Accumulation Ratio (AR) |
1.23; 1.25 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02713529). 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.