A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma

Odronextamab concentrations in serum when administered with chemotherapy

Part 1, Maintenance period and Part 2, Induction period

Time frame: Up to 30 months

Odronextamab concentrations in serum when administered as monotherapy

Part 1 and Part 2, Maintenance period

Time frame: Up to 30 months

Incidence of anti-odronextamab antibodies (ADAs)

Part 1 and Part 2

Time frame: Up to 30 months

Titers of ADAs to odronextamab

Part 1 and Part 2

Time frame: Up to 30 months

Incidence of neutralizing antibodies (NAb) to odronextamab

Part 1 and Part 2

Time frame: Up to 30 months

Best overall response (BOR) as assessed by the investigator

Part 1, end of Induction period and end of Maintenance period

Time frame: Up to 30 months

Progression free survival (PFS) as assessed by ICR

Part 2

Time frame: Up to 5 years

CR30 as assessed by local investigator

Part 2

Time frame: Up to 30 months

Change in patient reported physical functioning scale scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC-QLQ-C30)

Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

Time frame: Up to 5 years

PFS as assessed by local investigator

Part 2

Time frame: Up to 5 years

Event-free survival (EFS) as assessed by ICR

Part 2

Time frame: Up to 5 years

EFS as assessed by local investigator

Part 2

Time frame: Up to 5 years

Overall Survival (OS)

Part 2

Time frame: Up to 5 years

BOR as assessed by local investigator

Part 2

Time frame: Up to 30 months

BOR as assessed by ICR

Part 2

Time frame: Up to 30 months

Duration of response (DOR) assessed by ICR

Part 2

Time frame: Up to 5 years

DOR as assessed by local investigator

Part 2

Time frame: Up to 5 years

Time to next anti-lymphoma treatment (TTNT)

Part 2

Time frame: Up to 5 years

Incidence of TEAEs

Part 2

Time frame: Up to 2 years

Severity of TEAEs

Part 2

Time frame: Up to 2 years

Change in patient reported health related quality of life (HRQoL) as measured by EORTC-QLQ-C30

Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

Time frame: Up to 5 years

Change in cancer disease as measured by EORTC-QLQ-C30

Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

Time frame: Up to 5 years

Change in treatment related symptoms as measured by EORTC-QLQ-C30

Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.

Time frame: Up to 5 years

Change in patient-reported lymphoma disease as measured by the Lymphoma Subscale of the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS)

Part 2 The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.

Time frame: Up to 5 years

Change in treatment-related symptoms as measured by the FACT-LymS

Part 2 The FACT-LymS includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.

Time frame: Up to 5 years

Change in patient-reported general health status per EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

Part 2 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".

Time frame: Up to 5 years

Change in patient-reported treatment side effects burden per Functional Assessment of Cancer Therapy-General Global Population Item 5 (FACT-G GP5)

Part 2 A single item GP5 of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).

Time frame: Up to 5 years

Change in Patient Global Impression of Severity (PGIS)

Part 2 The PGIS includes a single-item to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. Patients will choose the response that best describes the severity of their overall cancer symptoms with options on a 5-point scale ranging from 1 (No symptoms) to 4 (Very Severe).

Time frame: Up to 5 years

Change in Patient Global Impression of Change (PGIC)

Part 2 The PGIC item includes a single-item to assess how a patient perceives their overall change in health status since the start of study treatment. Patients will choose from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse); 1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little Worse, 6-Moderately Worse, 7-Much Worse.

Time frame: Up to 5 years

Change in score of the FACT-G GP5 item in the patient population

Part 2 A single item GP5 of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).

Time frame: Up to 5 years