Last reviewed · How we verify
Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas
Phase 1, PHASE2 trial testing Nivolumab in Peripheral T Cell Lymphoma in 18 participants. Completed in 20 September 2022.
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 7 November 2018 |
| Primary completion | 26 May 2021 |
| Estimated completion | 20 September 2022 |
| Sites | 3 locations across United States |
University of Colorado, Denver
Adults 18 to 80, any sex, with Peripheral T Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Efficacy will be measured according to 2017 RECIL criteria. Responses will be assessed by the investigator and will be based on PET/CT scan to be obtained after 6 cycles of induction chemotherapy.
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab and EPOCH | 11 |
Toxicity analysis of nivolumab will be summarized by dose and severity as assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0 and relationship to study drug or the amount of grade 4-5 non-hematologic toxicities.
| Group | Value | 95% CI |
|---|---|---|
| Nivolumab and EPOCH | 18 |
Efficacy will be measured according to 2017 RECIL criteria. Responses will be assessed by the investigator and will be based on PET/CT scan to be obtained after 6 cycles of induction chemotherapy. Complete response (CR), complete disappearance of all target lesions and Deauville score 1-3. Partial response (PR), ≥30% decrease in the sum of longest diameters of target lesions but not a CR and Deauville score 4-5. Stable disease (SD), \<30% decrease or ≤ 20% increase in the sum of longest diameters of target lesions. Progressive disease (PD), \>20% increase in the sum of longest diameters of tar
| Group | Value | 95% CI |
|---|---|---|
| Nivo and EPOCH | 16 |
Efficacy will be measured according to 2017 RECIL criteria. Responses will be assessed by the investigator and will be based on PET/CT scan to be obtained after 6 cycles of induction chemotherapy.
| Group | Value | 95% CI |
|---|---|---|
| Nivo and EPOCH | 14.5 | 7.5 – 22.2 |
Efficacy will be measured according to 2017 RECIL criteria. Responses will be assessed by the investigator and will be based on PET/CT scan to be obtained after 6 cycles of induction chemotherapy. Events defined as start of new treatment, progression, or death.
| Group | Value | 95% CI |
|---|---|---|
| Nivo and EPOCH | 10.5 | 6.9 – 20.5 |
We assessed PD-L1 expression using immunohistochemistry on pre-treatment tumor tissue. The outcome of measurement was complete response yes vs. no. Using logistic regression, we assessed if the percentage of PDL1+ cells was predictive of achieving a complete response.
| Group | Value | 95% CI |
|---|---|---|
| Nivo and EPOCH | 0.985 | 0.938 – 1.034 |
Time frame: up to 100 days after last dose of nivolumab. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Nivolumab and EPOCH |
|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | — |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — |
| Sepsis | Infections and infestations | — |
| Encephalopathy | Nervous system disorders | — |
| Clostridioides difficile | Gastrointestinal disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Abdominal Pain | Gastrointestinal disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Dehydration | General disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Fever | General disorders | — |
| Gastritis | Gastrointestinal disorders | — |
| chest wall pain | Cardiac disorders | — |
| iliacus/iliopsoas hematoma | Injury, poisoning and procedural complications | — |
| Altered Mental Status | Psychiatric disorders | — |
| Cellulitis | Infections and infestations | — |
| Chemotherapy Extravasation | Injury, poisoning and procedural complications | — |
| COVID-19 pneumonia | Infections and infestations | — |
| dermatologic toxicity c/w Stevens Johnson Syndrome | Skin and subcutaneous tissue disorders | — |
| Elevated Transaminases | Blood and lymphatic system disorders | — |
| intra-abdominal infection | Infections and infestations | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Infected Biopsy Site | Infections and infestations | — |
| Reaction | System | Nivolumab and EPOCH |
|---|---|---|
| neuropathy | Nervous system disorders | — |
| Edema | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Pain | General disorders | — |
| Fatigue | General disorders | — |
| Fever | General disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Chills | General disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Headache | General disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Sinus tachycardia | Cardiac disorders | — |
| weakness | General disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Confusion | Psychiatric disorders | — |
| Congestion | Respiratory, thoracic and mediastinal disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Mucositis | Skin and subcutaneous tissue disorders | — |
| pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Acute Kidney Injury | Renal and urinary disorders | — |
| Hypertension | Vascular disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| hypotension | Vascular disorders | — |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Cellulitis | Infections and infestations | — |
| Thromboembolic event | Vascular disorders | — |
| Dry eye | Eye disorders | — |
| Erythema multiforme | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Febrile Neutropenia, Respiratory Failure, Sepsis, Encephalopathy, Clostridioides difficile, Hypoxia, Abdominal Pain, Atrial fibrillation.
Data from ClinicalTrials.gov NCT03586999 adverse events section.
This regimen aims to become the first line treatment for peripheral T cell lymphoma, using nivolumab with the standard of care chemotherapy.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03586999.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing