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Ipilimumab vs Ipilimumab Plus Nivolumab in Patients With Stage III-IV Melanoma Who Have Progressed or Relapsed on PD-1 Inhibitor Therapy
Phase 2 trial testing ipilimumab in Melanoma in 20 participants. Completed in 13 February 2019.
| Lead sponsor | Parker Institute for Cancer Immunotherapy |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 21 June 2016 |
| Primary completion | 27 August 2018 |
| Estimated completion | 13 February 2019 |
| Sites | 7 locations across United States |
Parker Institute for Cancer Immunotherapy
18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate was defined as any participant who had a Complete Response (CR) or Partial Response (PR) as defined by RECIST v1.1 by week 18 of treatment.
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab and Nivolumab | 20 | 3 – 56 |
| Ipilimumab | 56 | 21 – 86 |
Disease Control Rate was defined as any participant who achieved a complete response (CR), partial response (PR), or who remained stable (SD) as defined in Recist v1.1 at week 18.
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab and Nivolumab | 60 | 26 – 88 |
| Ipilimumab | 67 | 30 – 93 |
Time to Treatment Failure is defined as the time from treatment initiation until the participant starts a subsequent therapy or death, whichever comes first.
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab and Nivolumab | 26.9 | 0.7 – NA |
| Ipilimumab | 13.6 | 2.8 – NA |
Overall Survival is defined as the time of treatment initiation to death by any cause
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab and Nivolumab | 2 | |
| Ipilimumab | 1 |
The occurrence of Grade 3 and Grade 4 adverse events (AE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab and Nivolumab | 4 | |
| Ipilimumab | 5 |
Disease Control Rate was defined as any participant who achieved a complete response (CR), partial response (PR), or who remained stable (SD) as defined in Recist v1.1 at week 12.
| Group | Value | 95% CI |
|---|---|---|
| Ipilimumab and Nivolumab | 60.0 | 26.2 – 87.8 |
| Ipilimumab | 55.6 | 21.2 – 86.3 |
Time frame: Adverse events were monitored during each cycle. Adverse events were reported until 30 days after the last dose of study treatment had been administered.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ipilimumab and Nivolumab | Ipilimumab |
|---|---|---|---|
| Colitis | Gastrointestinal disorders | — | — |
| Confusional state | Psychiatric disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Pericardial effusion | Cardiac disorders | — | — |
| Adrenal insufficiency | Endocrine disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Hip fracture | Injury, poisoning and procedural complications | — | — |
| Neutrophil count decreased | Investigations | — | — |
| White blood cell count decreased | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Pleural effusion | Reproductive system and breast disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Reaction | System | Ipilimumab and Nivolumab | Ipilimumab |
|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Pyrexia | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Hypophysitis | Endocrine disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Chills | General disorders | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| White blood cell count decreased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Weight decreased | Investigations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Erythema multiforme | Skin and subcutaneous tissue disorders | — | — |
| Hair color changes | Skin and subcutaneous tissue disorders | — | — |
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | — | — |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | — | — |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Faecaloma | Gastrointestinal disorders | — | — |
| Flatulence | Gastrointestinal disorders | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Colitis, Confusional state, Diarrhoea, Abdominal pain, Vomiting, Hypertension, Hypotension, Pericardial effusion.
Data from ClinicalTrials.gov NCT02731729 adverse events section.
The purpose of this research study is to learn whether patients whose disease grows after being treated with nivolumab or pembrolizumab respond to ipilimumab (Yervoy®) alone or in combination with nivolumab (Opdivo®).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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