Trial · NCT02713529

Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer

NCT02713529, Phase 1, Phase 2, Completed, AmMax Bio, Inc.; results first posted 2020-06-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer. Trials, record NCT02713529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02713529

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer
NCT number: NCT02713529
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 117 participants, actual
Lead sponsor: AmMax Bio, Inc.
Conditions: Pancreatic Cancer, Colorectal Cancer, Non-Small Cell Lung Cancer
Interventions: AMG820 and pembrolizumab
First posted: 2016-03-18
Last updated: 2023-01-20
Other registries' IDs: eudract:2016-001080-36
Results first posted: 2020-06-01

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Participants With Dose Limiting Toxicities (DLT)	The DLT evaluation period was Day 1 to Day 21	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.
Primary	Participants With Treatment -Emergent Adverse Events (TEAEs)	Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2	TEAEs include any adverse event starting on or after the first dose of AMG 820 or pembrolizumab. Relation to study drugs was determined by the investigator. Adverse events (AEs) were graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. Errors in the case report form design resulted in investigators misunderstanding the CTCAE definition for severity grade 5. Therefore data are not reported for severity grade 5. Readers are referred to the 'Fatal TEAE' line in the table below for counts of participants who died during the TEAE timeframe.
Primary	Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment	Day 1 up to 207 days for Part 1; Day 1 up to 572 days for Part 2	TEAEs include any adverse event starting on or after the first dose of AMG 820 or pembrolizumab. Relation to study drugs was determined by the investigator. Adverse events (AEs) were graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. Errors in the case report form design resulted in investigators misunderstanding the CTCAE definition for severity grade 5. Therefore data are not reported for severity grade 5. Readers are referred to the 'Fatal TEAE' line in the table below for counts of participants who died during the TEAE timeframe.
Primary	Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment	Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2	TEAEs include any adverse event starting on or after the first dose of AMG 820 or pembrolizumab. Relation to study drugs was determined by the investigator. Adverse events (AEs) were graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. Errors in the case report form design resulted in investigators misunderstanding the CTCAE definition for severity grade 5. Therefore data are not reported for severity grade 5. Readers are referred to the 'Fatal TEAE' line in the table below for counts of participants who died during the TEAE timeframe.
Primary	Objective Response Rate (ORR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST)	Baseline: Day -28; Treatment: up to Month 13.7	ORR was defined as the percentage of participants with a best overall response of complete response or partial response assessed by the investigator using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). Response was based on the size of tumors assessed by computed tomography (CT) or magnetic resonance imaging (MRI). During treatment radiographic imaging was performed at Week 10 and repeated at least every 10 weeks until disease progression. Complete response (iCR): Disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented was required. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (iPR): Decrease in tumor burden ≥ 30% relative to baseline. Confirmation by a consecutive assessment at least 4 weeks after first documentation required.
Secondary	Time to Response (TTR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) For Participants Who Responded	Day 1 up to Month 16 (max time to censoring)	Time to response was defined as the time from first dose of AMG 820 until first documented complete or partial response per irRECIST divided by 365.25 days/12.
Secondary	Time to Progression (TTP) for Participants Who Had Progressive Disease	Day 1 up to 14.4 months (max time to censoring)	Time to progression was defined as the time from first dose of AMG 820 until first documented progressive disease per irRECIST divided by 365.25 days/12.
Secondary	Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12	Day 1 up to Month 6 or Month 12	Overall survival time was calculated as the number of days from the first administration of AMG 820 to date of death or censoring divided by (365.25/12). Data are reported as the percentage of participants who were alive at Month 6 and Month 12.
Secondary	Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12	Day 1 up to Month 6 or Month 12	Progression-free survival time was calculated as the number of days from the first administration of AMG 820 to date of progressive disease or death or censoring divided by (365.25/12). Data are reported as the percentage of participants who were alive and progression-free at Month 6 and Month 12.
Secondary	AMG 820 Pharmacokinetic Parameter by Dose Group: Time of Maximum Observed Concentration (Tmax) During Treatment Cycles 1 + 2	Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Participants With Dose Limiting Toxicities (DLT)	The DLT evaluation period was Day 1 to Day 21	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Participants With Treatment -Emergent Adverse Events (TEAEs)	Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment	Day 1 up to 207 days for Part 1; Day 1 up to 572 days for Part 2	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment	Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Objective Response Rate (ORR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST)	Baseline: Day -28; Treatment: up to Month 13.7	Safety Analysis Set	percentage of participants	NUMBER
SECONDARY	Time to Response (TTR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) For Participants Who Responded	Day 1 up to Month 16 (max time to censoring)	Safety Analysis Set	month	MEAN
SECONDARY	Time to Progression (TTP) for Participants Who Had Progressive Disease	Day 1 up to 14.4 months (max time to censoring)	Safety Analysis Set	month	MEAN
SECONDARY	Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12	Day 1 up to Month 6 or Month 12	Safety Analysis Set	percentage of participants	NUMBER
SECONDARY	Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12	Day 1 up to Month 6 or Month 12	Safety Analysis Set	percentage of participants	NUMBER
SECONDARY	AMG 820 Pharmacokinetic Parameter by Dose Group: Time of Maximum Observed Concentration (Tmax) During Treatment Cycles 1 + 2	Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36	Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.	hour	MEDIAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group440

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Participants With Dose Limiting Toxicities (DLT)	Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	Participants with treatment emergent DLTs	0	Participants
Participants With Dose Limiting Toxicities (DLT)	Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	Participants with treatment emergent DLTs	1	Participants
Participants With Dose Limiting Toxicities (DLT)	Part 2, Group 1: CRC MMR-proficient	Participants with treatment emergent DLTs	3	Participants
Participants With Dose Limiting Toxicities (DLT)	Part 2, Group 2: Pancreatic Cancer	Participants with treatment emergent DLTs	2	Participants
Participants With Dose Limiting Toxicities (DLT)	Part 2, Group 3: NSCLC PD-L1 Low, Naïve	Participants with treatment emergent DLTs	0	Participants
Participants With Dose Limiting Toxicities (DLT)	Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	Participants with treatment emergent DLTs	1	Participants
Participants With Dose Limiting Toxicities (DLT)	Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	Participants with treatment emergent DLTs	0	Participants
Participants With Dose Limiting Toxicities (DLT)	Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	DLT: Autoimmune pancreatitis	0	Participants
Participants With Dose Limiting Toxicities (DLT)	Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	DLT: Autoimmune pancreatitis	1	Participants
Participants With Dose Limiting Toxicities (DLT)	Part 2, Group 1: CRC MMR-proficient	DLT: Autoimmune pancreatitis	0	Participants

1 to 10 of 440Source ClinicalTrials.gov

See all 440 results by group

Participant flow21

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	8
Overall Study	STARTED	Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	7
Overall Study	STARTED	Part 2, Group 1: CRC MMR-proficient	42
Overall Study	STARTED	Part 2, Group 2: Pancreatic Cancer	31
Overall Study	STARTED	Part 2, Group 3: NSCLC PD-L1 Low, Naïve	4
Overall Study	STARTED	Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	19
Overall Study	STARTED	Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	6
Overall Study	COMPLETED	Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	1
Overall Study	COMPLETED	Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	3
Overall Study	COMPLETED	Part 2, Group 1: CRC MMR-proficient	11

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events466

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	AMG 820 1100 MG	35	98
other	Anaemia	Blood and lymphatic system disorders	AMG 820 1400 MG	4	18
other	Bradycardia	Cardiac disorders	AMG 820 1100 MG	1	98
other	Bradycardia	Cardiac disorders	AMG 820 1400 MG	1	18
other	Hypothyroidism	Endocrine disorders	AMG 820 1100 MG	6	98
other	Hypothyroidism	Endocrine disorders	AMG 820 1400 MG	0	18
other	Parathyroid disorder	Endocrine disorders	AMG 820 1100 MG	0	98
other	Parathyroid disorder	Endocrine disorders	AMG 820 1400 MG	1	18
other	Periorbital oedema	Eye disorders	AMG 820 1100 MG	38	98
other	Periorbital oedema	Eye disorders	AMG 820 1400 MG	10	18

1 to 10 of 466Source ClinicalTrials.gov

See all 466 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AMG 820 1100 MG	12	98
Total, all-cause mortality	AMG 820 1400 MG	1	18
Total, other adverse events	AMG 820 1100 MG	97	98
Total, other adverse events	AMG 820 1400 MG	18	18
Total, serious adverse events	AMG 820 1100 MG	70	98
Total, serious adverse events	AMG 820 1400 MG	10	18

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33046621	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
AMG 820 1100 MG vs AMG 820 1400 MG: deaths from any cause	Trial comparisons
AMG 820 1100 MG vs AMG 820 1400 MG: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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