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An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma
Phase 1, PHASE2 trial testing Mosunetuzumab SC in Non-Hodgkin Lymphoma, Follicular Lymphoma in 8 participants. Terminated before completion.
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 10 May 2022 |
| Primary completion | 19 July 2023 |
| Estimated completion | 19 July 2023 |
| Sites | 17 locations across Belgium, United Kingdom, Germany, Canada, Australia, United States |
Hoffmann-La Roche — full company profile →
18 and older, any sex, with Non-Hodgkin Lymphoma, Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | 100 |
Best ORR is defined as the fraction of participants with complete response (CR) or partial response (PR) at any time as determined by the investigator using Lugano 2014 criteria.
| Group | Value | 95% CI |
|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | 62.5 |
| Group | Value | 95% CI |
|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | NA | ± NA |
| Group | Value | 95% CI |
|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | 0.00983 | ± NA |
| Group | Value | 95% CI |
|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | 0.0556 | ± 109.6 |
| Group | Value | 95% CI |
|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | 0.164 | ± 90.5 |
| Group | Value | 95% CI |
|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | 0.166 | ± 83.2 |
| Group | Value | 95% CI |
|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | 2.18 | ± 48.8 |
| Group | Value | 95% CI |
|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | 4.02 | ± 86.3 |
| Group | Value | 95% CI |
|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | 2.90 | ± 81.8 |
| Group | Value | 95% CI |
|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | 37.5 |
| Group | Value | 95% CI |
|---|---|---|
| Subcutaneous (SC) Mosunetuzumab in Combination With Intravenous (IV) Tiragolumab | NA |
Time frame: From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Subcutaneous (SC) Mosunetu… |
|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| COVID-19 | Infections and infestations | — |
| Pneumonia aspiration | Infections and infestations | — |
| Septic shock | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Cerebellar haematoma | Nervous system disorders | — |
| Reaction | System | Subcutaneous (SC) Mosunetu… |
|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — |
| Injection site reaction | General disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Asthenia | General disorders | — |
| Oedema peripheral | General disorders | — |
| Hypokalaemia | Metabolism and nutrition disorders | — |
| Hypophosphataemia | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Osteoporosis | Musculoskeletal and connective tissue disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Ear congestion | Ear and labyrinth disorders | — |
| Retinal detachment | Eye disorders | — |
| Abdominal distension | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Malignant dysphagia | Gastrointestinal disorders | — |
| Oral pain | Gastrointestinal disorders | — |
| Chills | General disorders | — |
| Fatigue | General disorders | — |
| Malaise | General disorders | — |
| Pyrexia | General disorders | — |
| Cytokine release syndrome | Immune system disorders | — |
| COVID-19 | Infections and infestations | — |
| Cytomegalovirus infection reactivation | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Rhinovirus infection | Infections and infestations | — |
| Fractured sacrum | Injury, poisoning and procedural complications | — |
| Blood creatinine increased | Investigations | — |
| Gamma-glutamyltransferase increased | Investigations | — |
| Cachexia | Metabolism and nutrition disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Headache | Nervous system disorders | — |
| Paraesthesia | Nervous system disorders | — |
Most-reported serious reactions: Abdominal pain, Diarrhoea, COVID-19, Pneumonia aspiration, Septic shock, Fall, Cerebellar haematoma.
Data from ClinicalTrials.gov NCT05315713 adverse events section.
This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in combination with tiragolumab, with or without atezolizumab, in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who have received at least two previous lines of systemic therapy.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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