NCT02713529 is a Phase 1, PHASE2 clinical trial of AMG820 and pembrolizumab in Pancreatic Cancer, sponsored by AmMax Bio, Inc..

Who is sponsoring NCT02713529?

NCT02713529 is sponsored by AmMax Bio, Inc..

What drugs are being tested in NCT02713529?

Interventions in NCT02713529: AMG820 and pembrolizumab.

What condition does NCT02713529 study?

NCT02713529 studies Pancreatic Cancer, Colorectal Cancer, Non-Small Cell Lung Cancer.

Is NCT02713529 still recruiting?

NCT02713529 is currently completed. Last updated 20 January 2023.

Are results published for NCT02713529?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-01-20 · How we verify

NCT02713529

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Results posted Last updated 20 January 2023

What this trial tests

Phase 1, PHASE2 trial testing AMG820 and pembrolizumab in Pancreatic Cancer in 117 participants. Completed in 17 May 2019.

Timeline

14 April 2016

Primary endpoint
2 January 2019

17 May 2019

Quick facts

Lead sponsor	AmMax Bio, Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	117
Start date	14 April 2016
Primary completion	2 January 2019
Estimated completion	17 May 2019
Sites	15 locations across Belgium, Germany, Canada, Australia, United States, Spain

Drugs / interventions tested

AMG820 and pembrolizumab — full drug profile →

Conditions studied

Pancreatic Cancer — all drugs for Pancreatic Cancer →
Colorectal Cancer — all drugs for Colorectal Cancer →
Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

AmMax Bio, Inc. — full company profile →

Who can join

18 and older, any sex, with Pancreatic Cancer or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants With Dose Limiting Toxicities (DLT) Primary · 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.

Participants with treatment emergent DLTs

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	1
Part 2, Group 1: CRC MMR-proficient	3
Part 2, Group 2: Pancreatic Cancer	2
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	1
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	0

DLT: Autoimmune pancreatitis

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	1
Part 2, Group 1: CRC MMR-proficient	0
Part 2, Group 2: Pancreatic Cancer	0
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	0
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	0

DLT: Autoimmune hepatitis

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	1
Part 2, Group 1: CRC MMR-proficient	0
Part 2, Group 2: Pancreatic Cancer	0
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	0
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	0

DLT: Cholecystitis

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	1
Part 2, Group 1: CRC MMR-proficient	0
Part 2, Group 2: Pancreatic Cancer	0
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	0
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	0

DLT: Electrolyte imbalance

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	1
Part 2, Group 1: CRC MMR-proficient	0
Part 2, Group 2: Pancreatic Cancer	0
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	0
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	0

DLT: Fatigue

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	0
Part 2, Group 1: CRC MMR-proficient	1
Part 2, Group 2: Pancreatic Cancer	0
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	0
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	0

DLT: Aspartate aminotransferase increased

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	0
Part 2, Group 1: CRC MMR-proficient	1
Part 2, Group 2: Pancreatic Cancer	1
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	0
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	0

DLT: Lipase increased

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	0
Part 2, Group 1: CRC MMR-proficient	0
Part 2, Group 2: Pancreatic Cancer	0
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	1
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	0

Participants With Treatment -Emergent Adverse Events (TEAEs) Primary · 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 repo

>=1 TEAE

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	8
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	7
Part 2, Group 1: CRC MMR-proficient	41
Part 2, Group 2: Pancreatic Cancer	31
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	4
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	19
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	6

Grade >=3

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	7
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	7
Part 2, Group 1: CRC MMR-proficient	40
Part 2, Group 2: Pancreatic Cancer	30
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	4
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	19
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	6

Grade >=4

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	2
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	4
Part 2, Group 1: CRC MMR-proficient	24
Part 2, Group 2: Pancreatic Cancer	26
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	2
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	12
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	4

Grade >=5

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	NA
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	NA
Part 2, Group 1: CRC MMR-proficient	NA
Part 2, Group 2: Pancreatic Cancer	NA
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	NA
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	NA
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	NA

Serious AE

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	5
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	2
Part 2, Group 1: CRC MMR-proficient	31
Part 2, Group 2: Pancreatic Cancer	23
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	3
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	11
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	5

Leading to interruption of AMG 820

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	4
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	3
Part 2, Group 1: CRC MMR-proficient	23
Part 2, Group 2: Pancreatic Cancer	7
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	1
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	7
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	2

Leading to discontinuation AMG 820

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	0
Part 2, Group 1: CRC MMR-proficient	6
Part 2, Group 2: Pancreatic Cancer	5
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	2
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	1
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	3

---- SAE leading to d/c AMG 820

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	0
Part 2, Group 1: CRC MMR-proficient	4
Part 2, Group 2: Pancreatic Cancer	4
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	1
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	0
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	2

Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment Primary · Day 1 up to 207 days for Part 1; Day 1 up to 572 days for Part 2

>=1 TEAE

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	5
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	7
Part 2, Group 1: CRC MMR-proficient	41
Part 2, Group 2: Pancreatic Cancer	25
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	4
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	14
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	6

Grade >=3

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	3
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	5
Part 2, Group 1: CRC MMR-proficient	28
Part 2, Group 2: Pancreatic Cancer	11
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	1
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	10
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	6

Grade >=4

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	1
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	1
Part 2, Group 1: CRC MMR-proficient	5
Part 2, Group 2: Pancreatic Cancer	5
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	2
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	2

Grade >=5

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	NA
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	NA
Part 2, Group 1: CRC MMR-proficient	NA
Part 2, Group 2: Pancreatic Cancer	NA
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	NA
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	NA
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	NA

Serious AE

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	2
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	2
Part 2, Group 1: CRC MMR-proficient	12
Part 2, Group 2: Pancreatic Cancer	4
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	3
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	3

Leading to interruption of AMG 820

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	2
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	3
Part 2, Group 1: CRC MMR-proficient	16
Part 2, Group 2: Pancreatic Cancer	7
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	5
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	2

Leading to discontinuation AMG 820

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	0
Part 2, Group 1: CRC MMR-proficient	3
Part 2, Group 2: Pancreatic Cancer	3
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	1
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	0
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	3

---- SAE leading to d/c AMG 820

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	0
Part 2, Group 1: CRC MMR-proficient	3
Part 2, Group 2: Pancreatic Cancer	2
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	0
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	2

Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment Primary · Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2

>=1 TEAE

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	5
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	7
Part 2, Group 1: CRC MMR-proficient	39
Part 2, Group 2: Pancreatic Cancer	24
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	4
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	13
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	6

Grade >=3

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	2
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	5
Part 2, Group 1: CRC MMR-proficient	29
Part 2, Group 2: Pancreatic Cancer	9
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	1
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	10
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	4

Grade >=4

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	1
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	1
Part 2, Group 1: CRC MMR-proficient	5
Part 2, Group 2: Pancreatic Cancer	4
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	2
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	2

Grade >=5

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	NA
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	NA
Part 2, Group 1: CRC MMR-proficient	NA
Part 2, Group 2: Pancreatic Cancer	NA
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	NA
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	NA
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	NA

Serious AE

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	2
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	2
Part 2, Group 1: CRC MMR-proficient	16
Part 2, Group 2: Pancreatic Cancer	5
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	3
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	4

Leading to interruption of PEM

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	1
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	3
Part 2, Group 1: CRC MMR-proficient	15
Part 2, Group 2: Pancreatic Cancer	6
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	5
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	2

Leading to discontinuation AMG 820

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	0
Part 2, Group 1: CRC MMR-proficient	4
Part 2, Group 2: Pancreatic Cancer	2
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	1
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	1
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	3

---- SAE leading to d/c AMG 820

Group	Value	95% CI
Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg	0
Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg	0
Part 2, Group 1: CRC MMR-proficient	3
Part 2, Group 2: Pancreatic Cancer	1
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	0
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	2

Objective Response Rate (ORR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) Primary · 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

Group	Value	95% CI
Part 1: AMG 820 + Pem	0.0	0.00 – 0.00
Part 2, Group 1: CRC MMR-proficient	4.9	0.60 – 16.53
Part 2, Group 2: Pancreatic Cancer	0.0	0.0 – 0.0
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0.0	0.0 – 0.0
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	5.3	0.13 – 26.03
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	0.0	0.0 – 0.0

Time to Response (TTR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) For Participants Who Responded Secondary · 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.

Group	Value	95% CI
Part 2, Group 1: CRC MMR-proficient	2.1587	2.004 – 2.168
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	2.0698	NA – NA

Time to Progression (TTP) for Participants Who Had Progressive Disease Secondary · 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.

Group	Value	95% CI
Part 1: AMG 820 + Pem	2.1865	0.460 – 5.552
Part 2, Group 1: CRC MMR-proficient	3.0691	0.559 – 8.411
Part 2, Group 2: Pancreatic Cancer	2.3878	0.296 – 4.698
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	4.6762	2.070 – 6.604
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	6.0863	1.150 – 11.992
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	7.7864	1.938 – 13.667

Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 Secondary · 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.

Month 6

Group	Value	95% CI
Part 1: AMG 820 + Pem 200 mg	59.077	32.25 – 78.28
Part 2, Group 1: CRC MMR-proficient	53.915	40.00 – 63.93
Part 2, Group 2: Pancreatic Cancer	16.705	7.40 – 29.24
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	75.000	22.34 – 94.63
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	52.105	31.91 – 68.93
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	41.667	9.26 – 72.47

Month 12

Group	Value	95% CI
Part 1: AMG 820 + Pem 200 mg	47.262	21.19 – 69.63
Part 2, Group 1: CRC MMR-proficient	38.963	25.77 – 51.94
Part 2, Group 2: Pancreatic Cancer	8.353	2.22 – 19.81
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	25.00	2.08 – 60.89
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	34.737	17.37 – 52.79
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	41.667	9.26 – 72.47

Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 Secondary · 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.

Month 6

Group	Value	95% CI
Part 1: AMG 820 + Pem 200 mg	10.476	1.23 – 31.40
Part 2, Group 1: CRC MMR-proficient	13.490	5.99 – 24.04
Part 2, Group 2: Pancreatic Cancer	0.000	0.00 – 0.00
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	25.000	2.08 – 60.89
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	26.471	10.67 – 45.41
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	33.333	7.37 – 62.95

Month 12

Group	Value	95% CI
Part 1: AMG 820 + Pem 200 mg	0.000	0.00 – 0.00
Part 2, Group 1: CRC MMR-proficient	5.396	1.36 – 13.77
Part 2, Group 2: Pancreatic Cancer	0.000	0.00 – 0.00
Part 2, Group 3: NSCLC PD-L1 Low, Naïve	0.000	0.00 – 0.00
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low	6.618	0.77 – 21.97
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High	33.333	7.37 – 62.95

AMG 820 Pharmacokinetic Parameter by Dose Group: Time of Maximum Observed Concentration (Tmax) During Treatment Cycles 1 + 2 Secondary · 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

Cycle 1

Group	Value	95% CI
AMG 820 1100 mg	2.0	1.0 – 170
AMG 820 1400 mg	2.0	1.0 – 7.0

Cycle 2

Group	Value	95% CI
AMG 820 1100 mg	3.00	1.00 – 25.0
AMG 820 1400 mg	2.00	1.00 – 25.0

AMG 820 Pharmacokinetic Parameter by Dose Group: Maximum Observed Drug Concentration (Cmax) During Treatment Cycles 1 + 2 Secondary · 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

Cycle 1

Group	Value	95% CI
AMG 820 1100 mg	331	± 27
AMG 820 1400 mg	485	± 23

Cycle 2

Group	Value	95% CI
AMG 820 1100 mg	363	± 32
AMG 820 1400 mg	536	± 21

AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Last (AUClast) During Treatment Cycles 1 + 2 Secondary · 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

AUClast is the area under the serum concentration-time curve from time zero to time of last quantifiable concentration.

Cycle 1

Group	Value	95% CI
AMG 820 1100 mg	55100	± 37
AMG 820 1400 mg	80400	± 33

Cycle 2

Group	Value	95% CI
AMG 820 1100 mg	55200	± 38
AMG 820 1400 mg	73500	± 45

Adverse events — posted to ClinicalTrials.gov

Time frame: The TEAE timeframe was Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2. The median time frame is 122 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AMG 820 1100 MG

Serious: 70/98 (71%)

Deaths: 12/98

AMG 820 1400 MG

Serious: 10/18 (56%)

Deaths: 1/18

Serious adverse events (107 terms)

Reaction	System	AMG 820 1100 MG	AMG 820 1400 MG
Pyrexia	General disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Bile duct obstruction	Hepatobiliary disorders	—	—
Device related infection	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Hepatitis	Hepatobiliary disorders	—	—
Cellulitis	Infections and infestations	—	—
Lung infection	Infections and infestations	—	—
Transaminases increased	Investigations	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Cerebrovascular accident	Nervous system disorders	—	—
Acute kidney injury	Renal and urinary disorders	—	—

Other adverse events (126 terms — click to expand)

Reaction	System	AMG 820 1100 MG	AMG 820 1400 MG
Aspartate aminotransferase increased	Investigations	—	—
Fatigue	General disorders	—	—
Periorbital oedema	Eye disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Amylase increased	Investigations	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Lipase increased	Investigations	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—
Hypertension	Vascular disorders	—	—
Face oedema	General disorders	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—
Blood alkaline phosphatase increased	Investigations	—	—
Vomiting	Gastrointestinal disorders	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—
Chills	General disorders	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—
Headache	Nervous system disorders	—	—
Oedema peripheral	General disorders	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Candida infection	Infections and infestations	—	—
Transaminases increased	Investigations	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—
Haematuria	Renal and urinary disorders	—	—

Most-reported serious reactions: Pyrexia, Urinary tract infection, Pleural effusion, Anaemia, Abdominal pain, Asthenia, Bile duct obstruction, Device related infection.

Data from ClinicalTrials.gov NCT02713529 adverse events section.

Sponsor's own description

A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in subjects with select advanced solid tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Inflammation and tumor progression: signaling pathways and targeted intervention.
Zhao H, Wu L, Yan G, Chen Y, et al · · 2021 · cited 1932× · PMID 34248142 · DOI 10.1038/s41392-021-00658-5
Macrophages as regulators of tumour immunity and immunotherapy.
DeNardo DG, Ruffell B. · · 2019 · cited 1903× · PMID 30718830 · DOI 10.1038/s41577-019-0127-6
Macrophages as tools and targets in cancer therapy.
Mantovani A, Allavena P, Marchesi F, Garlanda C. · · 2022 · cited 1279× · PMID 35974096 · DOI 10.1038/s41573-022-00520-5
Colony-stimulating factor 1 receptor (CSF1R) inhibitors in cancer therapy.
Cannarile MA, Weisser M, Jacob W, Jegg AM, et al · · 2017 · cited 796× · PMID 28716061 · DOI 10.1186/s40425-017-0257-y
Targeting tumor-associated macrophages to synergize tumor immunotherapy.
Xiang X, Wang J, Lu D, Xu X. · · 2021 · cited 712× · PMID 33619259 · DOI 10.1038/s41392-021-00484-9
Progress in tumor-associated macrophage (TAM)-targeted therapeutics.
Ngambenjawong C, Gustafson HH, Pun SH. · · 2017 · cited 659× · PMID 28449873 · DOI 10.1016/j.addr.2017.04.010
Tumor-associated macrophages: from basic research to clinical application.
Yang L, Zhang Y. · · 2017 · cited 654× · PMID 28241846 · DOI 10.1186/s13045-017-0430-2
Targeting M2-like tumor-associated macrophages is a potential therapeutic approach to overcome antitumor drug resistance.
Wang S, Wang J, Chen Z, Luo J, et al · · 2024 · cited 406× · PMID 38341519 · DOI 10.1038/s41698-024-00522-z

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02713529 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AmMax Bio, Inc.
Last refreshed: 20 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02713529.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02713529

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (107 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Pancreatic Cancer

Other AmMax Bio, Inc. trials

Verify against primary sources