Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer

Conditions

Esophageal Cancer, Gastric Cancer, Stomach Cancer

Brief summary

This main purpose of this clinical study is to learn about the safety and activity of margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and gastroesophageal junction cancer.

Detailed description

Detailed Description: Both margetuximab and pembrolizumab are monoclonal antibodies used in combination to treat HER2+ gastric and gastroesophageal junction cancer. This study has two parts: Dose Escalation and Dose Expansion. The Dose Escalation phase of the study will evaluate safety of escalating doses of the combination treatment. The Dose Expansion phase will evaluate safety and activity of the combination in patients with gastric or gastroesophageal cancer once the final dose and schedule are defined. In addition, a cohort of patients with HER2+ 3+ gastric cancer patients will be enrolled in the Dose Expansion Phase.

Catenacci DV, Kang YK, Uronis HE, Lee KW, Ng MC, Enzinger PC, Park SH, Gold PJ, Lacy J, Hochster HS, Oh SC, Kim YH, Marrone KA, Kelly RJ, Juergens RA, Kim JG, Alcindor T, Sym SJ, Song EK, Chee CE, Chao Y, Kim S, Oh DY, Yen J, Odegaard JI, Lagow E, Li D, Sun J, Kaminker P, Moore PA, Rosales MK, Park H.

2023-04-016 citations

10.46883/2023.25920992

Margetuximab plus pembrolizumab in patients with previously treated, HER2-positive gastro-oesophageal adenocarcinoma (CP-MGAH22-05): a single-arm, phase 1b-2 trial.

Catenacci DVT, Kang YK, Park H, Uronis HE, Lee KW, Ng MCH, Enzinger PC, Park SH, Gold PJ, Lacy J, Hochster HS, Oh SC, Kim YH, Marrone KA, Kelly RJ, Juergens RA, Kim JG, Bendell JC, Alcindor T, Sym SJ, Song EK, Chee CE, Chao Y, Kim S, Lockhart AC, Knutson KL, Yen J, Franovic A, Nordstrom JL, Li D, Wigginton J, Davidson-Moncada JK, Rosales MK, Bang YJ, CP-MGAH22-5 Study Group.

2020-07-09152 citations

10.1016/s1470-2045(20)30326-0

Ipilimumab or FOLFOX with Nivolumab and Trastuzumab in previously untreated HER2-positive locally advanced or metastatic EsophagoGastric Adenocarcinoma - the randomized phase 2 INTEGA trial (AIO STO 0217)

Joseph Tintelnot, Eray Goekkurt, Mascha Binder, Peter Thuss‐Patience, Sylvie Lorenzen et al. (17 authors)

BMC Cancer2020-06-0129 citations

10.1186/s12885-020-06958-3

Antitumor activity of margetuximab (M) plus pembrolizumab (P) in patients (pts) with advanced HER2+ (IHC3+) gastric carcinoma (GC).

Daniel V.T. Catenacci, Kian‐Huat Lim, Hope E. Uronis, Yoon‐Koo Kang, Matthew Chau Hsien Ng et al. (20 authors)

Journal of Clinical Oncology2019-01-2919 citations

10.1200/jco.2019.37.4_suppl.65

Biomarker-guided enrichment of the antitumor activity of margetuximab (M) plus pembrolizumab (P) in patients with advanced HER2+ gastric adenocarcinoma (GEA)

Daniel V.T. Catenacci, H. Park, Hope E. Uronis, Yoon‐Koo Kang, Matthew Ng et al. (20 authors)

Annals of Oncology2018-10-013 citations

10.1093/annonc/mdy282.046

Margetuximab (M) plus pembrolizumab (P) in ERBB2-amplified PD-L1+ gastroesophageal adenocarcinoma (GEA) post trastuzumab (T).

Daniel V.T. Catenacci, Haeseong Park, Hope E. Uronis, Yoon‐Koo Kang, Jill Lacy et al. (20 authors)

Journal of Clinical Oncology2018-05-2013 citations

10.1200/jco.2018.36.15_suppl.4030

Phase 1b/2 study of margetuximab (M) plus pembrolizumab (P) in advanced HER2+ gastroesophageal junction (GEJ) or gastric (G) adenocarcinoma (GEA).

Daniel V.T. Catenacci, Haeseong Park, A. Craig Lockhart, Philip J. Gold, Peter C. Enzinger et al. (20 authors)

Journal of Clinical Oncology2018-02-0116 citations

10.1200/jco.2018.36.4_suppl.140

A phase 1b/2, open label, dose-escalation study of margetuximab (M) in combination with pembrolizumab (P) in patients with relapsed/refractory advanced HER2+ gastroesophageal (GEJ) junction or gastric (G) cancer.

Daniel V.T. Catenacci, Sunnie S. Kim, Philip J. Gold, Philip Agop Philip, Peter C. Enzinger et al. (18 authors)

Journal of Clinical Oncology2017-02-0112 citations

10.1200/jco.2017.35.4_suppl.tps219

Clonal Evolutionary Analysis during HER2 Blockade in HER2-Positive Inflammatory Breast Cancer: A Phase II Open-Label Clinical Trial of Afatinib +/- Vinorelbine

Gerald Goh, Ramona Schmid, Kelly Guiver, Wichit Arpornwirat, Imjai Chitapanarux et al. (19 authors)

PLoS Medicine2016-12-0636 citations

10.1371/journal.pmed.1002136

Interventions

BIOLOGICALMargetuximab 10 mg/kg

Margetuximab treatment is administered intravenously (IV) once every 21-day cycle

BIOLOGICALMargetuximab 15 mg

Margetuximab treatment is administered IV once every 21-day cycle

BIOLOGICALPembrolizumab

Pembrolizumab treatment is administered IV once every 21-day cycle

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Signed written informed consent. 2. Age ≥ 18 years old (or minimum age based upon local regulations) 3. Unresectable locally advanced or metastatic histologically proven HER2+ gastroesophageal junction (GEJ) or gastric cancer. Gastric Cancer Expansion Phase will include only gastric cancer patients with 3+ HER2 positivity. 4. HER2+ as 3+ (as defined in AJCC staging manual 8th edition) by IHC or in-situ hybridation (ISH) amplified. 5. Have received prior treatment with trastuzumab. 6. Have received treatment with at least one or more lines of cytotoxic chemotherapy in the metastatic setting. 7. Resolution of chemotherapy, immunotherapy or radiation-related toxicities. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 9. Life expectancy ≥ 12 weeks. 10. Measurable disease as per RECIST 1.1 criteria.

Exclusion criteria

1. Patients with symptomatic central nervous system (CNS) metastases. 2. Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment. 3. History of prior allogeneic bone marrow, stem-cell or solid organ transplantation. 4. Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 3 weeks prior to the initiation of study drug. 5. Treatment with radiation therapy within 3 weeks prior to the initiation of study drug administration. 6. Treatment with corticosteroids (≥10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration. 7. History of clinically-significant cardiovascular disease. 8. Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation. 9. History of (non-infectious) pneumonitis that required steroids or presence of active pneumonitis 10. Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis. 11. Evidence of active viral, bacterial, or systemic fungal infection.

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients With Dose Limiting Toxicities	21 days	Characterize maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of margetuximab when administered in combination with pembrolizumab
Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).	up to 24 months	The number of patients that experience either an AE or a SAE during the study participation
Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment	12 months	Investigate the preliminary anti-tumor activity as measured by response to treatment of margetuximab when administered in combination with pembrolizumab, using conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria	12 Months	Investigate the preliminary anti-tumor activity, as measured by objective response rate (ORR) of margetuximab when administered in combination with pembrolizumab, using immune-related response criteria (irRC).
Duration of Response	up to 24 months	Duration of response is calculated at the time from CR or PR to relapse or cancer progression.

Secondary

Measure	Time frame	Description
Maximum Concentration of Margetuximab at Steady State	At end of infusion on Cycle 1, Day 1. Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months	Measurement of PK characteristics is limited to margetuximab. No analysis of pembrolizumab was conducted.
Area Under the Concentration Time Curve at Steady State (AUC ss)	Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months	AUC is a mathematical calculation that describes the variation in drug concentration in the blood over time.
Overall Survival (OS)	24 Months	The median length of time between first dose of study medication and death from any cause.
Volume of Distribution at Steady State	Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit average 12 months .	The volume of distribution is related to a whether how much drug is distributed to body tissues, or remains in the bloodstream.
Terminal Half-life	Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit average 12 months .	Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.
Clearance	Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months.	Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time.
Progression Free Survival (PFS)	24 Months	The interval between the first dose of study medication and progression of disease or death from any cause.
Change From Baseline in Pharmacodynamic Markers in Whole Blood	from first dose to the end of treatment, average about 12 months	The planned assessment included examination of markers of T-cell activation
Analysis of HER2 Tumor Cell Membrane Expression in Biopsy Specimens Before and After Treatment	from first dose to the end of treatment, average 12 months.	—
Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)	Assessed Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Day 1 of every odd cycle, and end of treatment visit, average 12 months	—

Countries

Canada, Singapore, South Korea, Taiwan, United States

Participant flow

Participants by arm

Arm	Count
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) combination treatment is administered once every 21-day cycle	3
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) combination treatment is administered once every 21-day cycle	92
Total	95

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	8
Overall Study	concern for anemia	0	1
Overall Study	Death	0	1
Overall Study	decreased heart function	0	1
Overall Study	no measurable cancer for evaluation	0	1
Overall Study	Physician Decision	1	2
Overall Study	progression of cancer	1	72
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Total
Age, Continuous	62.7 years STANDARD_DEVIATION 9.87	60.2 years STANDARD_DEVIATION 12.83	60.3 years STANDARD_DEVIATION 12.71
ECOG Performance Status 0	0 participants	33 participants	33 participants
ECOG Performance Status 1	3 participants	59 participants	62 participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	2 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants	88 Participants	91 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	2 Participants	2 Participants
HER2 IHC 3+ and PD-L1 positive	0 Participants	25 Participants	25 Participants
HER2 status using immunohistochemistry (IHC) IHC 2+	2 Participants	21 Participants	23 Participants
HER2 status using immunohistochemistry (IHC) IHC 3+	1 Participants	71 Participants	72 Participants
PD-L1 Status PD-L1 negative	1 Participants	43 Participants	44 Participants
PD-L1 Status PD-L1 positive	1 Participants	33 Participants	34 Participants
PD-L1 Status unknown	1 Participants	16 Participants	17 Participants
Primary tumor location Gastric	0 participants	61 participants	61 participants
Primary tumor location Gastroesophageal junction	3 participants	31 participants	34 participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Asian	0 Participants	51 Participants	51 Participants
Race (NIH/OMB) Black or African American	0 Participants	3 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) White	3 Participants	34 Participants	37 Participants
Region of Enrollment Canada	0 participants	3 participants	3 participants
Region of Enrollment Singapore	0 participants	8 participants	8 participants
Region of Enrollment South Korea	0 participants	42 participants	42 participants
Region of Enrollment Taiwan	0 participants	1 participants	1 participants
Region of Enrollment United States	3 participants	38 participants	41 participants
Sex: Female, Male Female	0 Participants	17 Participants	17 Participants
Sex: Female, Male Male	3 Participants	75 Participants	78 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	3 / 3	69 / 92
other Total, other adverse events	3 / 3	86 / 92
serious Total, serious adverse events	2 / 3	38 / 92

Outcome results

Primary

Duration of Response

Duration of response is calculated at the time from CR or PR to relapse or cancer progression.

Time frame: up to 24 months

Population: There were no responders in the 10mg/kg group

Arm	Measure	Value (MEDIAN)
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Duration of Response	12.1 months

Primary

Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment

Investigate the preliminary anti-tumor activity as measured by response to treatment of margetuximab when administered in combination with pembrolizumab, using conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Time frame: 12 months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment	0 Participants
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment	18 Participants

Primary

Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria

Investigate the preliminary anti-tumor activity, as measured by objective response rate (ORR) of margetuximab when administered in combination with pembrolizumab, using immune-related response criteria (irRC).

Time frame: 12 Months

Population: Analysis is limited to patients receiving margetuximab (15 mg/kg) and pembrolizumab (200 mg)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria	0 Participants
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria	19 Participants

Primary

Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).

The number of patients that experience either an AE or a SAE during the study participation

Time frame: up to 24 months

Population: All patients receiving at least 1 dose of margetuximab or pembrolizumab

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).	3 Participants
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).	86 Participants

Primary

Number of Patients With Dose Limiting Toxicities

Characterize maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of margetuximab when administered in combination with pembrolizumab

Time frame: 21 days

Population: Dose escalation cohorts to determine the expansion cohort dose.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Number of Patients With Dose Limiting Toxicities	0 Participants
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Number of Patients With Dose Limiting Toxicities	0 Participants

Secondary

Analysis of HER2 Tumor Cell Membrane Expression in Biopsy Specimens Before and After Treatment

Time frame: from first dose to the end of treatment, average 12 months.

Population: Sample collection was planned for the Margetuximab (15 mg/kg) plus pembrolizumab (200 mg) cohort only. No samples were received that could be tested. The analysis could not be conducted.

Secondary

Area Under the Concentration Time Curve at Steady State (AUC ss)

AUC is a mathematical calculation that describes the variation in drug concentration in the blood over time.

Time frame: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Area Under the Concentration Time Curve at Steady State (AUC ss)	1710 mcg/mL* day	Geometric Coefficient of Variation 0.358
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Area Under the Concentration Time Curve at Steady State (AUC ss)	2720 mcg/mL* day	Geometric Coefficient of Variation 0.329

Secondary

Change From Baseline in Pharmacodynamic Markers in Whole Blood

The planned assessment included examination of markers of T-cell activation

Time frame: from first dose to the end of treatment, average about 12 months

Population: Analysis was not performed. A number of samples were degraded in shipping rendering insufficient samples to conduct the analysis.

Secondary

Clearance

Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time.

Time frame: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Clearance	0.381 liters per day	Geometric Coefficient of Variation 0.0394
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Clearance	0.329 liters per day	Geometric Coefficient of Variation 0.296

Secondary

Maximum Concentration of Margetuximab at Steady State

Measurement of PK characteristics is limited to margetuximab. No analysis of pembrolizumab was conducted.

Time frame: At end of infusion on Cycle 1, Day 1. Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Maximum Concentration of Margetuximab at Steady State	197 mcg/mL	Geometric Coefficient of Variation 0.249
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Maximum Concentration of Margetuximab at Steady State	318 mcg/mL	Geometric Coefficient of Variation 0.168

Secondary

Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)

Time frame: Assessed Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Day 1 of every odd cycle, and end of treatment visit, average 12 months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)	1 Participants
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)	4 Participants

Secondary

Overall Survival (OS)

The median length of time between first dose of study medication and death from any cause.

Time frame: 24 Months

Arm	Measure	Value (MEDIAN)
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Overall Survival (OS)	7.0 months
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Overall Survival (OS)	12.7 months

Secondary

Progression Free Survival (PFS)

The interval between the first dose of study medication and progression of disease or death from any cause.

Time frame: 24 Months

Arm	Measure	Value (MEDIAN)
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Progression Free Survival (PFS)	1.4 months
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Progression Free Survival (PFS)	2.7 months

Secondary

Terminal Half-life

Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.

Time frame: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit average 12 months .

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Terminal Half-life	17.2 day	Geometric Coefficient of Variation 0.312
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Terminal Half-life	16.2 day	Geometric Coefficient of Variation 0.286

Secondary

Volume of Distribution at Steady State

The volume of distribution is related to a whether how much drug is distributed to body tissues, or remains in the bloodstream.

Time frame: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit average 12 months .

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Volume of Distribution at Steady State	7.7 liters	Geometric Coefficient of Variation 0.306
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Volume of Distribution at Steady State	6.37 liters	Geometric Coefficient of Variation 0.205

Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Duration of Response

Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment

Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria

Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).

Number of Patients With Dose Limiting Toxicities

Analysis of HER2 Tumor Cell Membrane Expression in Biopsy Specimens Before and After Treatment

Area Under the Concentration Time Curve at Steady State (AUC ss)

Change From Baseline in Pharmacodynamic Markers in Whole Blood

Clearance

Maximum Concentration of Margetuximab at Steady State

Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)

Overall Survival (OS)

Progression Free Survival (PFS)

Terminal Half-life

Volume of Distribution at Steady State