Colorectal Cancer, Non-Small Cell Lung Cancer, Pancreatic Cancer
Conditions
Keywords
Solid Tumor, Pancreatic Cancer, Colorectal Cancer, Non-Small Cell Lung Cancer
Brief summary
A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in subjects with select advanced solid tumors.
Detailed description
Phase 1b is AMG 820 dose determining and aimed at assessing the safety and tolerability of the selected starting dose of AMG 820 in combination with pembrolizumab. Phase 2 of the study will further evaluate safety and tolerability and additionally test whether AMG 820 can enhance the anti-tumor activity observed historically with pembrolizumab alone and/or overcome lack of response to pembrolizumab monotherapy in subjects with select solid tumors.
Interventions
BIOLOGICALAMG820 and pembrolizumab
Treatment with AMG820 and pembrolizumab
Sponsors
Merck Sharp & Dohme LLC
AmMax Bio, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| AMG 820 Pharmacokinetic Parameter by Dose Group: Maximum Observed Drug Concentration (Cmax) 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 | — |
| AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Last (AUClast) 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 | AUClast is the area under the serum concentration-time curve from time zero to time of last quantifiable concentration. |
| AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Over the Dose Interval (AUCtau) 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 | AUCtau is the area under the serum concentration-time curve over the dose interval tau, with tau equal to 21 days. |
| AMG 820 Pharmacokinetic Parameter by Dose Group: Minimum Observed Drug Concentration (Cmin) 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 | — |
| 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. |
| AMG 820 Pharmacokinetic Parameter by Dose Group: Volume of Distribution (Vz) 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 | Volume of distribution observed at terminal phase after intravenous dosing. |
| AMG 820 Pharmacokinetic Parameter by Dose Group: Drug Clearance (CL) 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 | Drug clearance observed after intravenous dosing. |
| AMG 820 Pharmacokinetic Parameter by Dose Group: Accumulation Ratio (AR) | 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 | Accumulation ratio is AUCtau following administration in Cycle 2 / AUCtau after administration in Cycle 1 |
| AMG 820 Pharmacokinetic Parameter by Dose Group: Terminal Elimination Half-life (t1/2z) 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 | — |
| 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. |
| 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. |
| 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. |
| 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 | — |
Countries
Australia, Belgium, Canada, Germany, Spain, United States
Participant flow
Recruitment details
This study was conducted at 15 centers in Australia, Canada, United States of America, and Europe.
Pre-assignment details
Part 1 was a phase Ib safety study comprised of two cohorts. Part 2 was a phase 2 safety and efficacy study comprised of 5 groups.
Participants by arm
| Arm | Count |
|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg Part 1 Cohort 2 includes participants with advanced solid tumors who were treated with 1100 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed. | 8 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg Part 1 Cohort 1 includes participants with advanced solid tumors who were treated with 1400 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.
If \>= 3 participants had dose limiting toxicities (DLTs), a second cohort was created with a lower AMG 820 dose + Pem 200 mg. | 7 |
| Part 2, Group 1: CRC MMR-proficient Group 1 is comprised of participants with colorectal cancer (CRC) who are proficient in mismatch repair genes (MMR).
AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent. | 42 |
| Part 2, Group 2: Pancreatic Cancer Group 2 is comprised of participants with advanced pancreatic cancer who are naïve to anti programmed-death 1 (PD-1), anti PD-ligand 1 (PD-L1), colony stimulating factor 1 (CSF-1) and colony stimulating factor 1 receptor (CSF-1R) therapies.
AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent. | 31 |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve Group 3 is comprised of participants with non-small cell lung cancer (NSCLC) who have low (\< 50%) tumor PD-L1- expression and are naïve to anti-PD-1/PD-L1/CSF-1/CSF-1R agents.
AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent. | 4 |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low Group 4a is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have low PD-L1 tumor expression (\<50%).
AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent. | 19 |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High Group 4b is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have high PD-L1 tumor expression (\>=50%).
AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent. | 6 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 3 | 3 | 26 | 27 | 3 | 13 | 3 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 4 | 2 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Part 2, Group 2: Pancreatic Cancer | Total | Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Part 2, Group 1: CRC MMR-proficient | Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg |
|---|---|---|---|---|---|---|---|---|
| Age, Customized 18-64 years | 4 Participants | 7 Participants | 3 Participants | 18 Participants | 64 Participants | 2 Participants | 24 Participants | 6 Participants |
| Age, Customized 65-74 years | 2 Participants | 6 Participants | 1 Participants | 10 Participants | 41 Participants | 6 Participants | 15 Participants | 1 Participants |
| Age, Customized 75-84 years | 0 Participants | 5 Participants | 0 Participants | 3 Participants | 11 Participants | 0 Participants | 3 Participants | 0 Participants |
| Age, Customized >=85 years | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Disease Stage at Screening Stage I | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Disease Stage at Screening Stage II | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 9 Participants | 1 Participants | 3 Participants | 0 Participants |
| Disease Stage at Screening Stage III | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 9 Participants | 0 Participants | 4 Participants | 0 Participants |
| Disease Stage at Screening Stage IV | 5 Participants | 16 Participants | 3 Participants | 26 Participants | 97 Participants | 6 Participants | 35 Participants | 6 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0 | 2 Participants | 4 Participants | 1 Participants | 7 Participants | 43 Participants | 6 Participants | 19 Participants | 4 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1 | 4 Participants | 15 Participants | 3 Participants | 24 Participants | 74 Participants | 2 Participants | 23 Participants | 3 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 2 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 3 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 4 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 5 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants | 0 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 19 Participants | 4 Participants | 29 Participants | 108 Participants | 8 Participants | 36 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 3 Participants | 0 Participants |
| Number of Prior Line of Therapy 0 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Prior Line of Therapy 1 | 0 Participants | 1 Participants | 3 Participants | 3 Participants | 9 Participants | 0 Participants | 2 Participants | 0 Participants |
| Number of Prior Line of Therapy 2 | 3 Participants | 7 Participants | 1 Participants | 13 Participants | 35 Participants | 1 Participants | 9 Participants | 1 Participants |
| Number of Prior Line of Therapy 3 | 3 Participants | 7 Participants | 0 Participants | 8 Participants | 36 Participants | 4 Participants | 11 Participants | 3 Participants |
| Number of Prior Line of Therapy 4 | 0 Participants | 1 Participants | 0 Participants | 5 Participants | 18 Participants | 1 Participants | 10 Participants | 1 Participants |
| Number of Prior Line of Therapy 5 | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 19 Participants | 2 Participants | 10 Participants | 2 Participants |
| Number of Prior Line of Therapy >5 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 5 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 17 Participants | 4 Participants | 26 Participants | 104 Participants | 8 Participants | 39 Participants | 5 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 1 Participants | 14 Participants | 43 Participants | 5 Participants | 16 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 18 Participants | 3 Participants | 17 Participants | 74 Participants | 3 Participants | 26 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 98 | 1 / 18 |
| other Total, other adverse events | 97 / 98 | 18 / 18 |
| serious Total, serious adverse events | 70 / 98 | 10 / 18 |
Outcome results
Primary
Objective Response Rate (ORR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST)
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.
Time frame: Baseline: Day -28; Treatment: up to Month 13.7
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Objective Response Rate (ORR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) | 0.0 percentage of participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Objective Response Rate (ORR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) | 4.9 percentage of participants |
| Part 2, Group 1: CRC MMR-proficient | Objective Response Rate (ORR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) | 0.0 percentage of participants |
| Part 2, Group 2: Pancreatic Cancer | Objective Response Rate (ORR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) | 0.0 percentage of participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Objective Response Rate (ORR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) | 5.3 percentage of participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Objective Response Rate (ORR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) | 0.0 percentage of participants |
Primary
Participants With Dose Limiting Toxicities (DLT)
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.
Time frame: The DLT evaluation period was Day 1 to Day 21
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Aspartate aminotransferase increased | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash maculo-papular | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash generalised | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune hepatitis | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Cholecystitis | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune pancreatitis | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Epilepsy | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Fatigue | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Lipase increased | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | Participants with treatment emergent DLTs | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Electrolyte imbalance | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Cholecystitis | 1 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | Participants with treatment emergent DLTs | 1 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Fatigue | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash maculo-papular | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune hepatitis | 1 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune pancreatitis | 1 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Electrolyte imbalance | 1 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash generalised | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Epilepsy | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Lipase increased | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Dose Limiting Toxicities (DLT) | DLT: Aspartate aminotransferase increased | 0 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash generalised | 1 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune pancreatitis | 0 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune hepatitis | 0 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Dose Limiting Toxicities (DLT) | DLT: Cholecystitis | 0 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Dose Limiting Toxicities (DLT) | DLT: Electrolyte imbalance | 0 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Dose Limiting Toxicities (DLT) | DLT: Fatigue | 1 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Dose Limiting Toxicities (DLT) | DLT: Aspartate aminotransferase increased | 1 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Dose Limiting Toxicities (DLT) | DLT: Lipase increased | 0 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Dose Limiting Toxicities (DLT) | DLT: Epilepsy | 0 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Dose Limiting Toxicities (DLT) | Participants with treatment emergent DLTs | 3 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash maculo-papular | 1 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Dose Limiting Toxicities (DLT) | DLT: Electrolyte imbalance | 0 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Dose Limiting Toxicities (DLT) | DLT: Lipase increased | 0 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune pancreatitis | 0 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Dose Limiting Toxicities (DLT) | DLT: Cholecystitis | 0 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Dose Limiting Toxicities (DLT) | Participants with treatment emergent DLTs | 2 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Dose Limiting Toxicities (DLT) | DLT: Aspartate aminotransferase increased | 1 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Dose Limiting Toxicities (DLT) | DLT: Fatigue | 0 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash maculo-papular | 0 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash generalised | 0 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune hepatitis | 0 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Dose Limiting Toxicities (DLT) | DLT: Epilepsy | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Dose Limiting Toxicities (DLT) | DLT: Cholecystitis | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Dose Limiting Toxicities (DLT) | DLT: Aspartate aminotransferase increased | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Dose Limiting Toxicities (DLT) | Participants with treatment emergent DLTs | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Dose Limiting Toxicities (DLT) | DLT: Lipase increased | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Dose Limiting Toxicities (DLT) | DLT: Epilepsy | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune hepatitis | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash generalised | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash maculo-papular | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune pancreatitis | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Dose Limiting Toxicities (DLT) | DLT: Electrolyte imbalance | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Dose Limiting Toxicities (DLT) | DLT: Fatigue | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Dose Limiting Toxicities (DLT) | DLT: Electrolyte imbalance | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash maculo-papular | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash generalised | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Dose Limiting Toxicities (DLT) | DLT: Cholecystitis | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune hepatitis | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Dose Limiting Toxicities (DLT) | DLT: Lipase increased | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune pancreatitis | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Dose Limiting Toxicities (DLT) | Participants with treatment emergent DLTs | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Dose Limiting Toxicities (DLT) | DLT: Fatigue | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Dose Limiting Toxicities (DLT) | DLT: Aspartate aminotransferase increased | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Dose Limiting Toxicities (DLT) | DLT: Epilepsy | 0 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Dose Limiting Toxicities (DLT) | DLT: Fatigue | 0 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Dose Limiting Toxicities (DLT) | DLT: Electrolyte imbalance | 0 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Dose Limiting Toxicities (DLT) | DLT: Aspartate aminotransferase increased | 0 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash generalised | 0 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune pancreatitis | 0 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Dose Limiting Toxicities (DLT) | DLT: Epilepsy | 0 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Dose Limiting Toxicities (DLT) | DLT: Rash maculo-papular | 0 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Dose Limiting Toxicities (DLT) | Participants with treatment emergent DLTs | 0 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Dose Limiting Toxicities (DLT) | DLT: Lipase increased | 0 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Dose Limiting Toxicities (DLT) | DLT: Autoimmune hepatitis | 0 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Dose Limiting Toxicities (DLT) | DLT: Cholecystitis | 0 Participants |
Primary
Participants With Treatment -Emergent Adverse Events (TEAEs)
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.
Time frame: Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c AMG 820 | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c PEM | 1 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | TEAE related to study procedure/activity | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation of PEM | 1 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | >=1 TEAE | 8 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c PEM | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=3 | 7 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Fatal TEAE | 1 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation AMG 820 | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c AMG 820 | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to interruption of AMG 820 | 4 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Serious AE | 5 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=4 | 2 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=5 | NA Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c AMG 820 | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Serious AE | 2 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation AMG 820 | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c PEM | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to interruption of AMG 820 | 3 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c PEM | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | TEAE related to study procedure/activity | 1 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | >=1 TEAE | 7 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation of PEM | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=3 | 7 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=4 | 4 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c AMG 820 | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=5 | NA Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c PEM | 3 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | TEAE related to study procedure/activity | 11 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation of PEM | 7 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | Serious AE | 31 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to interruption of AMG 820 | 23 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | Fatal TEAE | 4 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=4 | 24 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=5 | NA Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation AMG 820 | 6 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c AMG 820 | 2 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c PEM | 4 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | >=1 TEAE | 41 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c AMG 820 | 4 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=3 | 40 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to interruption of AMG 820 | 7 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation AMG 820 | 5 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c PEM | 4 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c PEM | 1 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | >=1 TEAE | 31 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | Fatal TEAE | 3 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=3 | 30 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | TEAE related to study procedure/activity | 5 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=4 | 26 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=5 | NA Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | Serious AE | 23 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation of PEM | 5 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c AMG 820 | 4 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=5 | NA Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c PEM | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | >=1 TEAE | 4 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=3 | 4 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=4 | 2 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c PEM | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | TEAE related to study procedure/activity | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation of PEM | 2 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | Serious AE | 3 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to interruption of AMG 820 | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation AMG 820 | 2 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c PEM | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c PEM | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | >=1 TEAE | 19 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=3 | 19 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=4 | 12 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=5 | NA Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | Serious AE | 11 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to interruption of AMG 820 | 7 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation AMG 820 | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c AMG 820 | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | TEAE related to study procedure/activity | 3 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation of PEM | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) | Fatal TEAE | 3 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c AMG 820 | 2 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation AMG 820 | 3 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | Serious AE | 5 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=5 | NA Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=4 | 4 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | Grade >=3 | 6 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | >=1 TEAE | 6 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | ---- SAE leading to d/c PEM | 2 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | TEAE related to study procedure/activity | 1 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | Fatal TEAE | 2 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to discontinuation of PEM | 3 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | Leading to interruption of AMG 820 | 2 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) | ----Non-serious AE leading to d/c PEM | 1 Participants |
Primary
Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment
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.
Time frame: Day 1 up to 207 days for Part 1; Day 1 up to 572 days for Part 2
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | >=1 TEAE | 5 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c AMG 820 | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Fatal TEAE | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c PEM | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation of PEM | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c PEM | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Serious AE | 2 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=5 | NA Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to interruption of AMG 820 | 2 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation AMG 820 | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=4 | 1 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c AMG 820 | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | TEAE related to study procedure/activity | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=3 | 3 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | >=1 TEAE | 7 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c AMG 820 | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c AMG 820 | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=5 | NA Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=4 | 1 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | TEAE related to study procedure/activity | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation of PEM | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c PEM | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation AMG 820 | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=3 | 5 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c PEM | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to interruption of AMG 820 | 3 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Serious AE | 2 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Fatal TEAE | 0 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Serious AE | 12 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation AMG 820 | 3 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c PEM | 3 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=5 | NA Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | TEAE related to study procedure/activity | 8 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to interruption of AMG 820 | 16 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=4 | 5 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=3 | 28 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c AMG 820 | 3 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Fatal TEAE | 1 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | >=1 TEAE | 41 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c AMG 820 | 0 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c PEM | 1 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation of PEM | 4 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=5 | NA Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Fatal TEAE | 0 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to interruption of AMG 820 | 7 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c AMG 820 | 2 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Serious AE | 4 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c PEM | 2 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c PEM | 1 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | >=1 TEAE | 25 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=3 | 11 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=4 | 5 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation AMG 820 | 3 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation of PEM | 3 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | TEAE related to study procedure/activity | 2 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation of PEM | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Serious AE | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c PEM | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=3 | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | TEAE related to study procedure/activity | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to interruption of AMG 820 | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=4 | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | >=1 TEAE | 4 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c PEM | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=5 | NA Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Fatal TEAE | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c AMG 820 | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation AMG 820 | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation AMG 820 | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c PEM | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation of PEM | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | >=1 TEAE | 14 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c AMG 820 | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=3 | 10 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to interruption of AMG 820 | 5 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=4 | 2 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Fatal TEAE | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | TEAE related to study procedure/activity | 3 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Serious AE | 3 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c PEM | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=5 | NA Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c AMG 820 | 0 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Serious AE | 3 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | TEAE related to study procedure/activity | 1 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation of PEM | 3 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to discontinuation AMG 820 | 3 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ----Non-serious AE leading to d/c PEM | 1 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | >=1 TEAE | 6 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c AMG 820 | 2 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=4 | 2 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | ---- SAE leading to d/c PEM | 2 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Leading to interruption of AMG 820 | 2 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Fatal TEAE | 1 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=5 | NA Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment | Grade >=3 | 6 Participants |
Primary
Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment
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.
Time frame: Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Serious AE | 2 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | TEAE related to study procedure/activity | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c AMG 820 | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c PEM | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c AMG 820 | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to interruption of PEM | 1 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c PEM | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=5 | NA Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation AMG 820 | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Fatal TEAE | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=4 | 1 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation of PEM | 0 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=3 | 2 Participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | >=1 TEAE | 5 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation AMG 820 | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c AMG 820 | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c PEM | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c AMG 820 | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | TEAE related to study procedure/activity | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c PEM | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to interruption of PEM | 3 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation of PEM | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=4 | 1 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=3 | 5 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=5 | NA Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Serious AE | 2 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Fatal TEAE | 0 Participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | >=1 TEAE | 7 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c PEM | 2 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation of PEM | 5 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=4 | 5 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c AMG 820 | 3 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=5 | NA Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=3 | 29 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Serious AE | 16 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to interruption of PEM | 15 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | TEAE related to study procedure/activity | 9 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Fatal TEAE | 1 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c PEM | 3 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | >=1 TEAE | 39 Participants |
| Part 2, Group 1: CRC MMR-proficient | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation AMG 820 | 4 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Serious AE | 5 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to interruption of PEM | 6 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation of PEM | 2 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=3 | 9 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=4 | 4 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c PEM | 1 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | TEAE related to study procedure/activity | 3 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | >=1 TEAE | 24 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Fatal TEAE | 0 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation AMG 820 | 2 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=5 | NA Participants |
| Part 2, Group 2: Pancreatic Cancer | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c PEM | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | >=1 TEAE | 4 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c PEM | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Fatal TEAE | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c AMG 820 | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation of PEM | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | TEAE related to study procedure/activity | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=5 | NA Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Serious AE | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to interruption of PEM | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c PEM | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=4 | 0 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation AMG 820 | 1 Participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=3 | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | TEAE related to study procedure/activity | 2 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to interruption of PEM | 5 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=4 | 2 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation AMG 820 | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c AMG 820 | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=5 | NA Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | >=1 TEAE | 13 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Fatal TEAE | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation of PEM | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c PEM | 1 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c PEM | 0 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=3 | 10 Participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Serious AE | 3 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation AMG 820 | 3 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Serious AE | 4 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | >=1 TEAE | 6 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=3 | 4 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | TEAE related to study procedure/activity | 1 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to discontinuation of PEM | 3 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=4 | 2 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Grade >=5 | NA Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c AMG 820 | 1 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c AMG 820 | 2 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Fatal TEAE | 1 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ----Non-serious AE leading to d/c PEM | 1 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | ---- SAE leading to d/c PEM | 2 Participants |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment | Leading to interruption of PEM | 2 Participants |
Secondary
AMG 820 Pharmacokinetic Parameter by Dose Group: Accumulation Ratio (AR)
Accumulation ratio is AUCtau following administration in Cycle 2 / AUCtau after administration in Cycle 1
Time frame: 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
Population: Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Accumulation Ratio (AR) | 1.23 ratio | Geometric Coefficient of Variation 18 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Accumulation Ratio (AR) | 1.25 ratio | Geometric Coefficient of Variation 16 |
Secondary
AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Last (AUClast) During Treatment Cycles 1 + 2
AUClast is the area under the serum concentration-time curve from time zero to time of last quantifiable concentration.
Time frame: 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
Population: Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Last (AUClast) During Treatment Cycles 1 + 2 | Cycle 1 | 55100 hr*ug/mL | Geometric Coefficient of Variation 37 |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Last (AUClast) During Treatment Cycles 1 + 2 | Cycle 2 | 55200 hr*ug/mL | Geometric Coefficient of Variation 38 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Last (AUClast) During Treatment Cycles 1 + 2 | Cycle 1 | 80400 hr*ug/mL | Geometric Coefficient of Variation 33 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Last (AUClast) During Treatment Cycles 1 + 2 | Cycle 2 | 73500 hr*ug/mL | Geometric Coefficient of Variation 45 |
Secondary
AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Over the Dose Interval (AUCtau) During Treatment Cycles 1 + 2
AUCtau is the area under the serum concentration-time curve over the dose interval tau, with tau equal to 21 days.
Time frame: 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
Population: Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Over the Dose Interval (AUCtau) During Treatment Cycles 1 + 2 | Cycle 1 | 59300 hr*ug/mL | Geometric Coefficient of Variation 33 |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Over the Dose Interval (AUCtau) During Treatment Cycles 1 + 2 | Cycle 2 | 75400 hr*ug/mL | Geometric Coefficient of Variation 35 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Over the Dose Interval (AUCtau) During Treatment Cycles 1 + 2 | Cycle 1 | 90000 hr*ug/mL | Geometric Coefficient of Variation 29 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Over the Dose Interval (AUCtau) During Treatment Cycles 1 + 2 | Cycle 2 | 114000 hr*ug/mL | Geometric Coefficient of Variation 31 |
Secondary
AMG 820 Pharmacokinetic Parameter by Dose Group: Drug Clearance (CL) During Treatment Cycles 1 + 2
Drug clearance observed after intravenous dosing.
Time frame: 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
Population: Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Drug Clearance (CL) During Treatment Cycles 1 + 2 | Cycle 2 | 18.6 liter/hour | Geometric Coefficient of Variation 30 |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Drug Clearance (CL) During Treatment Cycles 1 + 2 | Cycle 1 | 16.6 liter/hour | Geometric Coefficient of Variation 37 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Drug Clearance (CL) During Treatment Cycles 1 + 2 | Cycle 1 | 13.3 liter/hour | Geometric Coefficient of Variation 33 |
Secondary
AMG 820 Pharmacokinetic Parameter by Dose Group: Maximum Observed Drug Concentration (Cmax) During Treatment Cycles 1 + 2
Time frame: 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
Population: Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Maximum Observed Drug Concentration (Cmax) During Treatment Cycles 1 + 2 | Cycle 1 | 331 ug/mL | Geometric Coefficient of Variation 27 |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Maximum Observed Drug Concentration (Cmax) During Treatment Cycles 1 + 2 | Cycle 2 | 363 ug/mL | Geometric Coefficient of Variation 32 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Maximum Observed Drug Concentration (Cmax) During Treatment Cycles 1 + 2 | Cycle 1 | 485 ug/mL | Geometric Coefficient of Variation 23 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Maximum Observed Drug Concentration (Cmax) During Treatment Cycles 1 + 2 | Cycle 2 | 536 ug/mL | Geometric Coefficient of Variation 21 |
Secondary
AMG 820 Pharmacokinetic Parameter by Dose Group: Minimum Observed Drug Concentration (Cmin) During Treatment Cycles 1 + 2
Time frame: 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
Population: Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Minimum Observed Drug Concentration (Cmin) During Treatment Cycles 1 + 2 | Cycle 1 | 49.9 ug/mL | Geometric Coefficient of Variation 51 |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Minimum Observed Drug Concentration (Cmin) During Treatment Cycles 1 + 2 | Cycle 2 | 78.7 ug/mL | Geometric Coefficient of Variation 66 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Minimum Observed Drug Concentration (Cmin) During Treatment Cycles 1 + 2 | Cycle 1 | 90.9 ug/mL | Geometric Coefficient of Variation 35 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Minimum Observed Drug Concentration (Cmin) During Treatment Cycles 1 + 2 | Cycle 2 | 199 ug/mL | Geometric Coefficient of Variation 34 |
Secondary
AMG 820 Pharmacokinetic Parameter by Dose Group: Terminal Elimination Half-life (t1/2z) During Treatment Cycles 1 + 2
Time frame: 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
Population: Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Terminal Elimination Half-life (t1/2z) During Treatment Cycles 1 + 2 | Cycle 1 | 217 hour | Geometric Coefficient of Variation 26 |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Terminal Elimination Half-life (t1/2z) During Treatment Cycles 1 + 2 | Cycle 2 | 170 hour | Geometric Coefficient of Variation 16 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Terminal Elimination Half-life (t1/2z) During Treatment Cycles 1 + 2 | Cycle 1 | 214 hour | Geometric Coefficient of Variation 24 |
Secondary
AMG 820 Pharmacokinetic Parameter by Dose Group: Time of Maximum Observed Concentration (Tmax) During Treatment Cycles 1 + 2
Time frame: 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
Population: Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Time of Maximum Observed Concentration (Tmax) During Treatment Cycles 1 + 2 | Cycle 1 | 2.0 hour |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Time of Maximum Observed Concentration (Tmax) During Treatment Cycles 1 + 2 | Cycle 2 | 3.00 hour |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Time of Maximum Observed Concentration (Tmax) During Treatment Cycles 1 + 2 | Cycle 1 | 2.0 hour |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Time of Maximum Observed Concentration (Tmax) During Treatment Cycles 1 + 2 | Cycle 2 | 2.00 hour |
Secondary
AMG 820 Pharmacokinetic Parameter by Dose Group: Volume of Distribution (Vz) During Treatment Cycles 1 + 2
Volume of distribution observed at terminal phase after intravenous dosing.
Time frame: 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
Population: Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Volume of Distribution (Vz) During Treatment Cycles 1 + 2 | Cycle 1 | 5200 liter | Geometric Coefficient of Variation 35 |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Volume of Distribution (Vz) During Treatment Cycles 1 + 2 | Cycle 2 | 4560 liter | Geometric Coefficient of Variation 21 |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | AMG 820 Pharmacokinetic Parameter by Dose Group: Volume of Distribution (Vz) During Treatment Cycles 1 + 2 | Cycle 1 | 4110 liter | Geometric Coefficient of Variation 25 |
Secondary
Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and 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.
Time frame: Day 1 up to Month 6 or Month 12
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 | Month 6 | 59.077 percentage of participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 | Month 12 | 47.262 percentage of participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 | Month 12 | 38.963 percentage of participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 | Month 6 | 53.915 percentage of participants |
| Part 2, Group 1: CRC MMR-proficient | Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 | Month 12 | 8.353 percentage of participants |
| Part 2, Group 1: CRC MMR-proficient | Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 | Month 6 | 16.705 percentage of participants |
| Part 2, Group 2: Pancreatic Cancer | Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 | Month 6 | 75.000 percentage of participants |
| Part 2, Group 2: Pancreatic Cancer | Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 | Month 12 | 25.00 percentage of participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 | Month 6 | 52.105 percentage of participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 | Month 12 | 34.737 percentage of participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 | Month 12 | 41.667 percentage of participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12 | Month 6 | 41.667 percentage of participants |
Secondary
Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and 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.
Time frame: Day 1 up to Month 6 or Month 12
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 | Month 6 | 10.476 percentage of participants |
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 | Month 12 | 0.000 percentage of participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 | Month 6 | 13.490 percentage of participants |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 | Month 12 | 5.396 percentage of participants |
| Part 2, Group 1: CRC MMR-proficient | Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 | Month 6 | 0.000 percentage of participants |
| Part 2, Group 1: CRC MMR-proficient | Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 | Month 12 | 0.000 percentage of participants |
| Part 2, Group 2: Pancreatic Cancer | Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 | Month 12 | 0.000 percentage of participants |
| Part 2, Group 2: Pancreatic Cancer | Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 | Month 6 | 25.000 percentage of participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 | Month 12 | 6.618 percentage of participants |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 | Month 6 | 26.471 percentage of participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 | Month 12 | 33.333 percentage of participants |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12 | Month 6 | 33.333 percentage of participants |
Secondary
Time to Progression (TTP) for Participants Who Had Progressive Disease
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.
Time frame: Day 1 up to 14.4 months (max time to censoring)
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg | Time to Progression (TTP) for Participants Who Had Progressive Disease | 2.1865 month |
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Time to Progression (TTP) for Participants Who Had Progressive Disease | 3.0691 month |
| Part 2, Group 1: CRC MMR-proficient | Time to Progression (TTP) for Participants Who Had Progressive Disease | 2.3878 month |
| Part 2, Group 2: Pancreatic Cancer | Time to Progression (TTP) for Participants Who Had Progressive Disease | 4.6762 month |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Time to Progression (TTP) for Participants Who Had Progressive Disease | 6.0863 month |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | Time to Progression (TTP) for Participants Who Had Progressive Disease | 7.7864 month |
Secondary
Time to Response (TTR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) For Participants Who Responded
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.
Time frame: Day 1 up to Month 16 (max time to censoring)
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg | Time to Response (TTR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) For Participants Who Responded | 2.1587 month |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | Time to Response (TTR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) For Participants Who Responded | 2.0698 month |