| Primary | Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. Kaplan-Meier (K-M) method was used to estimate median OS. 80% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley. IxRS=Interactive response system. | ITT population included all the randomized participants. | Posted | | Median | 80% Confidence Interval | months | | From randomization to death (up to approximately 38.7 months) | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG002 | Tobemstomig | Participants received a fixed dose of tobemstomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0008.08(6.74 to 9.00)
- OG0014.76(2.83 to 5.82)
- OG0026.67(5.42 to 8.71)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Log Rank | | 0.7689 | P-value stratified by IxRS randomization stratification factors: Previous (neo-)adjuvant chemotherapy, chemoradiotherapy/definitive chemoradiotherapy in curative intention; Expression of PD-L1; Geographic region of the enrolling site. | Hazard Ratio (HR) | 1.05 | | | 2-Sided | 80 | 0.84 | 1.33 | | | | | Superiority | | |
|
| Secondary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Safety-evaluable population included all participants randomized to study treatment and who received any amount of the study treatment, whether prematurely withdrawn from the study or not. | Posted | | Count of Participants | | Participants | | Up to approximately 27 months | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG002 | Tobemstomig |
|
| Secondary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants who have achieved an objective response (OR), characterized by a complete response (CR) or partial response (PR), as per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. 80% CI for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off. | ITT population included all the randomized participants. | Posted | | Number | 80% Confidence Interval | percentage of participants | | Up to approximately 38.7months | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG002 | Tobemstomig |
|
| Secondary | Disease Control Rate (DCR) | DCR was defined as ORR plus stable disease rate (SDR). ORR was defined as the percentage of participants who have achieved an OR, characterized by a CR or PR as per RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and unequivocal progression of existing non-target lesions. 80% CI for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off. | ITT population included all the randomized participants. | Posted | | Number | 80% Confidence Interval | percentage of participants | | Up to approximately 38.7 months | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
|
| Secondary | Duration of Response (DoR) | DoR for participants with ORR was defined as time from first occurrence of a documented OR to PD as per RECIST v1.1 or death from any cause, whichever occurs first. ORR was defined as the percentage of participants who have achieved an OR, chaacterized by a CR or PR as per RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and unequivocal progression of existing non-target lesions. K-M method was used to estimate median DOR. 80% CI for median was computed using the method of Brookmeyer and Crowley. | ITT population included all the randomized participants. Overall number analyzed is the number of participants with a response. | Posted | | Median | 80% Confidence Interval | months | | Up to approximately 38.7 months | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | |
|
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of PD, as determined per RECIST v1.1, or death during the treatment period, or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS. 80% CI for median was computed using the method of Brookmeyer and Crowley. | ITT population included all the randomized participants. | Posted | | Median | 80% Confidence Interval | months | | Up to approximately 38.7 months | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG002 |
|
| Secondary | Percentage of Participants Reporting Clinically Meaningful Improvement in GHS/QoL, Emotional and Social Functioning as Measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire (QLQ)-C30 | EORTC QLQ-C30 is a cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), global health status (GHS)/quality of life (QoL), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). Functioning & symptom items were scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. The GHS/QoL questions were scored on a 7-point scale with scores ranging from 1=Very poor to 7=Excellent. All EORTC scales & single-item measures were linearly transformed to a score range of 0-100. High score for a functioning/GHS scale=high/healthy level of functioning/better HRQoL; however, high score for a symptom scale=high level of symptom severity. Clinically significant improvement=an increase of at least 10 points from baseline in GHS/QoL, emotional and social functioning. | Safety-evaluable population included all participants randomized to study treatment and who received any amount of the study treatment, whether prematurely withdrawn from the study or not. | Posted | | Number | | percentage of participants | | From baseline up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
|
| Secondary | Percentage of Participants Reporting Clinically Meaningful Improvement in GHS/QoL, Emotional and Social Functioning, as Measured by the EORTC QLQ - Item Library 97 (IL97) | EORTC QLQ-IL97, a reduced version of the QLQ-C30, is a cancer-specific instrument consisting of 17 questions to evaluate two aspects of participant functioning (emotional and social), GHS/QoL, and six symptoms (fatigue, nausea, vomiting, pain, appetite loss, & diarrhoea), with a recall period of the previous week. The scoring for the IL97 followed the same pattern as the QLQ-C30. Functioning & symptom items were scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. The GHS/QoL questions were scored on a 7-point scale with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a range of 0-100. High score for a functioning/GHS scale=high/healthy level of functioning/better HRQoL; however, high score for a symptom scale=high level of symptom severity. Clinically significant improvement=an increase of at least 10 points from baseline in GHS/QoL, emotional and social functioning. | Safety-evaluable population included all participants randomized to study treatment and who received any amount of the study treatment, whether prematurely withdrawn from the study or not. | Posted | | Number | | percentage of participants | | From baseline up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 |
|
| Secondary | Percentage of Participants Reporting a Clinically Meaningful Improvement in Dysphagia, as Measured by the EORTC QLQ for Oesophageal Cancer-18 (OES-18) | EORTC QLQ-OES18, a modular supplement to the EORTC QLQ-C30, is a cancer-specific instrument, consisting of 4 multiple-item scales (dysphagia, eating, reflux, and pain) and 6 single items (trouble swallowing saliva, choked when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking), with a recall period of the previous week. The scoring for the OES18 followed the same pattern as the QLQ-C30. Each symptom item was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0-100, with a high score reflecting a high level of symptom severity. Clinically significant improvement=an increase of at least 10 points from baseline in GHS/QoL, emotional and social functioning. | Safety-evaluable population included all participants randomized to study treatment and who received any amount of the study treatment, whether prematurely withdrawn from the study or not. | Posted | | Number | | percentage of participants | | From baseline up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
|
| Secondary | Serum Concentration of Nivolumab | | Pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of nivolumab and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliters (µg/mL) | | 4 hours (h) pre-dose, and 1 & 5 h post-dose on Day 1 of Cycle 1; pre-dose, and 0.5 & 4.5 h post-dose on Day 1 of Cycles 2 & 5; 168 h post-dose on Day 8 of Cycles 1 & 5; pre-dose, and 0.5 h post-dose on Day 1 of Cycles 3, 4 & 6 to 52 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Serum Concentration of Lomvastomig | | PK-evaluable population included all participants who received at least one dose of lomvastomig and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg/mL | | 4h pre-dose, and 1 & 5 h post-dose on Day 1 of Cycle 1; pre-dose, and 0.5 & 4.5 h post-dose on Day 1 of Cycles 2 & 5; 168 h post-dose on Day 8 of Cycles 1 & 5; pre-dose, and 0.5 h post-dose on Day 1 of Cycles 3, 4 & 6 to 19 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Serum Concentration of Tobemstomig | | PK-evaluable population included all participants who received at least one dose of tobemstomig and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg/mL | | 4h pre-dose, and 1 & 5 h post-dose on Day 1 of Cycle 1; pre-dose, and 0.5 & 4.5 h post-dose on Day 1 of Cycles 2 & 5; 168 h post-dose on Day 8 of Cycles 1 & 5; pre-dose, and 0.5 h post-dose on Day 1 of Cycles 3, 4 & 6 to 52 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Tobemstomig | Participants received a fixed dose of tobemstomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Maximum Observed Serum Concentration (Cmax) of Nivolumab | | PK-evaluable population included all participants who received at least one dose of nivolumab and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg/mL | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Cmax of Lomvastomig | | PK-evaluable population included all participants who received at least one dose of lomvastomig and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg/mL | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Cmax of Tobemstomig | | PK-evaluable population included all participants who received at least one dose of tobemstomig and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg/mL | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Tobemstomig | Participants received a fixed dose of tobemstomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Terminal Half-life (λz) of Nivolumab | | PK-evaluable population included all participants who received at least one dose of nivolumab and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | days | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | λz of Lomvastomig | | PK-evaluable population included all participants who received at least one dose of lomvastomig and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | days | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | λz of Tobemstomig | | PK-evaluable population included all participants who received at least one dose of tobemstomig and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | days | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Tobemstomig | Participants received a fixed dose of tobemstomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Area Under the Curve From Dosing to Last Concentration (AUClast) of Nivolumab | day*µg/mL=days-micrograms per milliliter. | PK-evaluable population included all participants who received at least one dose of nivolumab and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | day*µg/mL | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | AUClast of Lomvastomig | | PK-evaluable population included all participants who received at least one dose of lomvastomig and who had data from at least one post-dose sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | day*µg/mL | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | AUClast of Tobemstomig | | PK-evaluable population included all participants who received at least one dose of tobemstomig and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | day*µg/mL | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Tobemstomig | Participants received a fixed dose of tobemstomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Estimate of the Volume of Distribution at Steady-state (Vss_obs) of Nivolumab | | PK-evaluable population included all participants who received at least one dose of nivolumab and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liters | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Vss_obs of Lomvastomig | | PK-evaluable population included all participants who received at least one dose of lomvastomig and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liters | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Vss_obs of Tobemstomig | | PK-evaluable population included all participants who received at least one dose of tobemstomig and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liters | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Tobemstomig | Participants received a fixed dose of tobemstomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Total Clearance (Cl_obs) of Nivolumab | | PK-evaluable population included all participants who received at least one dose of nivolumab and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liters/day (L/day) | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Cl_obs of Lomvastomig | | PK-evaluable population included all participants who received at least one dose of lomvastomig and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/day | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Cl_obs of Tobemstomig | | PK-evaluable population included all participants who received at least one dose of tobemstomig and who had data from at least one post-dose sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/day | | Day 1 of Cycles 1 and 5 (1 Cycle=14 days) | | | | ID | Title | Description |
|---|
| OG000 | Tobemstomig | Participants received a fixed dose of tobemstomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Number of Participants With Anti-drug Antibodies (ADAs) to Nivolumab | Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following nivolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). | Safety-evaluable population included all participants randomized to nivolumab and who received any amount of nivolumab, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Count of Participants | | Participants | | Up to approximately 24 months | | | | ID | Title | Description |
|---|
| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Number of Participants With ADAs to Lomvastomig | Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following lomvastomig administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). | Safety-evaluable population included all participants randomized to lomvastomig and who received any amount of lomvastomig, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Count of Participants | | Participants | | Up to approximately 8.4 months | | | | ID | Title | Description |
|---|
| OG000 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Number of Participants With ADAs to Tobemstomig | Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following tobemstomig administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). | Safety-evaluable population included all participants randomized to tobemstomig and who received any amount of tobemstomig, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Count of Participants | | Participants | | Up to approximately 24 months | | | | ID | Title | Description |
|---|
| OG000 | Tobemstomig | Participants received a fixed dose of tobemstomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
| |
| Secondary | Change From Baseline in the Phenotype and Activation Status (Cluster of Differentiation 4 [CD4] Human Leukocyte Antigen - DR Isotype-positive [HLA-DR+] Kiel 67-positive [Ki67+]) of T-cell Subsets in the Peripheral Blood | Biomarker analyses were performed on peripheral blood samples collected from participants and assessed by flow cytometry. Zeros are present when no valid samples for PD assessments were collected/available at the respective visits. As the number of participants in the lomvastomig arm was more limited, chances to observe zeros are higher in this arm vs the other arms. | Safety-evaluable population included all participants randomized to study treatment and who received any amount of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Mean | Standard Deviation | cells per microliter (cells/µL) | | Day 1 of Cycles 1, 2, 3, 5, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51; Day 8 of Cycles 1 & 5; Study drug completion / Early discontinuation visit; (1 Cycle=14 days) (up to 24 months) | | | | ID | Title | Description |
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| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | |
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| Secondary | Change From Baseline in the Phenotype and Activation Status (Cluster of Differentiation 8 [CD8] HLA-DR+ Ki67+) of T-cell Subsets in the Peripheral Blood | Biomarker analyses were performed on peripheral blood samples collected from participants and assessed by flow cytometry. Zeros are present when no valid samples for PD assessments were collected/available at the respective visits. As the number of participants in the lomvastomig arm was more limited, chances to observe zeros are higher in this arm vs the other arms. | Safety-evaluable population included all participants randomized to study treatment and who received any amount of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | | Mean | Standard Deviation | cells/µL | | Day 1 of Cycles 1, 2, 3, 5, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51; Day 8 of Cycles 1 & 5; Study drug completion / Early discontinuation visit; (1 Cycle=14 days) (up to 24 months) | | | | ID | Title | Description |
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| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
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| Secondary | Baseline CD8 T-cell Infiltration, Poliferation (Cluster of Differentiation 8-positive Subunit Alpha [CD8A+] Ki67+) Expression in the Tumor Microenvironment | CD8 T-cell infiltration, poliferation (CD8A+ Ki67+) expression in the tumor microenvironment at baseline, was assessed from previously collected tumour samples (archival samples). For participants without an available archival tumor sample, a fresh tumor sample was collected during the screening. Both archival and screening samples were considered baseline samples to assess biomarkers within the tumor microenvironment. | Safety-evaluable population included all participants randomized to study treatment and who received any amount of the study treatment, whether prematurely withdrawn from the study or not. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified sampling. | Posted | | Mean | Standard Deviation | cells/µL | | At baseline | | | | ID | Title | Description |
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| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
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| Secondary | Baseline Anti-programmed Death-1 (PDL1) Expression in the Tumor Microenvironment | Anti-PDL1 expression in the tumor microenvironment at baseline, was assessed from previously collected tumour samples (archival samples). For participants without an available archival tumor sample, a fresh tumor sample was collected during the screening. Both archival and screening samples were considered as baseline samples to assess biomarkers within the tumor microenvironment. | Safety-evaluable population included all participants randomized to study treatment and who received any amount of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analyses at the specified sampling. | Posted | | Mean | Standard Deviation | percentage of cells | | At baseline | | | | ID | Title | Description |
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| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | |
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| Secondary | Baseline CD8A+ Anti-programmed Death-1-positive (PD1+) Expression in the Tumor Microenvironment | CD8A+ Anti-PD1+ expression in the tumor microenvironment at baseline, was assessed from previously collected tumour samples (archival samples). For participants without an available archival tumor sample, a fresh tumor sample was collected during the screening. Both archival and screening samples were considered as baseline samples to assess biomarkers within the tumor microenvironment. | Safety-evaluable population included all participants randomized to study treatment and who received any amount of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analyses at the specified sampling. | Posted | | Mean | Standard Deviation | cells per square millimeter (/mm^2) | | At Baseline | | | | ID | Title | Description |
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| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
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| Secondary | Baseline CD8A+ T-cell Immunoglobulin and Mucin Domain 3-positive (TIM3+) Expression in the Tumor Microenvironment | CD8A+ TIM3+ expression in the tumor microenvironment at baseline, was assessed from previously collected tumour samples (archival samples). For participants without an available archival tumor sample, a fresh tumor sample was collected during the screening. Both archival and screening samples were considered as baseline samples to assess biomarkers within the tumor microenvironment. | Safety-evaluable population included all participants randomized to study treatment and who received any amount of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analyses at the specified sampling. | Posted | | Mean | Standard Deviation | cells /mm^2 | | At Baseline | | | | ID | Title | Description |
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| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. |
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| Secondary | Baseline CD8A+ Lymphocyte-Activation Gene 3-positive (LAG3+) Expression in the Tumor Microenvironment | CD8A+ LAG3+ expression in the tumor microenvironment at baseline, was assessed from previously collected tumour samples (archival samples). For participants without an available archival tumor sample, a fresh tumor sample was collected during the screening. Both archival and screening samples were considered as baseline samples to assess biomarkers within the tumor microenvironment. | Safety-evaluable population included all participants randomized to study treatment and who received any amount of the study treatment, whether prematurely withdrawn from the study or not. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analyses at the specified sampling. | Posted | | Mean | Standard Deviation | cells/mm^2 | | At Baseline | | | | ID | Title | Description |
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| OG000 | Nivolumab | Participants received nivolumab, 240 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | | OG001 | Lomvastomig | Participants received a fixed dose of lomvastomig, 2100 mg, IV, Q2W, on Day 1 of each 14-day cycle until presence of clinical benefit, absence of unacceptable toxicity, or symptomatic deterioration due to PD. | |
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