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PhII Trial Panitumumab, Nivolumab, Ipilimumab in Kras/Nras/BRAF Wild-type MSS Refractory mCRC
Phase 2 trial testing Panitumumab in Colon Cancer in 56 participants. Completed in 2 December 2024.
| Lead sponsor | UNC Lineberger Comprehensive Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 9 March 2018 |
| Primary completion | 21 September 2020 |
| Estimated completion | 2 December 2024 |
| Sites | 5 locations across United States |
UNC Lineberger Comprehensive Cancer Center — full company profile →
Adults 18 to 120, any sex, with Colon Cancer. 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 (ORR) = CR + PR Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 32 | 21 – 45 |
Overall Response Rate (ORR) = irCR + irPR Per immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) for target and/or non-target lesions and assessed by imaging: Complete Response (irCR), Disappearance of all lesions, no new lesions, lymph nodes \< 10 mm in short axis; Partial Response (irPR), ≥30% decrease in the sum of target lesions and non-target lesions are irNN; Stable response (irSD), not meeting criteria for irCR, irPR, or irPD; Progressive Disease (irPD), ≥20% increase in tumor burden and minimum 5 mm absolute increase in compared to nadir; for no new non-target or (i
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 34 | 23 – 47 |
Median Progression Free Survival is the time at which 50% of the study population has experienced disease progression as defined by RECIST, irRECIST, or death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 6 | 5.5 – 7.4 |
Time from the first day of treatment until death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 17.4 | 14.2 – 27.5 |
Duration of response is the time from documentation of tumor response to disease progression.
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 5 | 3.3 – 9 |
The number of treatment-emergent grade 3 and 4 toxicities as defined by the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03) was reported.
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Open-label, Single Arm, Phase II | 1 |
Time frame: From Day 1 of treatment up to 3 years after completion of treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Open-label, Single Arm, Ph… |
|---|---|---|
| Adrenal insufficiency | Endocrine disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Fatigue | General disorders | — |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | — |
| Infections and infestations - Other, specify | Infections and infestations | — |
| Vomiting | Gastrointestinal disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Alkaline phosphatase increased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | — |
| Blood bilirubin increased | Investigations | — |
| Chest pain - cardiac | Cardiac disorders | — |
| Colonic obstruction | Gastrointestinal disorders | — |
| Colonic perforation | Gastrointestinal disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Delirium | Psychiatric disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Endocrine disorders - Other, specify | Endocrine disorders | — |
| Flu like symptoms | General disorders | — |
| Headache | Nervous system disorders | — |
| Hemolysis | Blood and lymphatic system disorders | — |
| Hypotension | Vascular disorders | — |
| Reaction | System | Open-label, Single Arm, Ph… |
|---|---|---|
| Rash acneiform | Skin and subcutaneous tissue disorders | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Fatigue | General disorders | — |
| Hypertension | Vascular disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Fever | General disorders | — |
| Alkaline phosphatase increased | Investigations | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Hypothyroidism | Endocrine disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — |
| Paronychia | Infections and infestations | — |
| Platelet count decreased | Investigations | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Headache | Nervous system disorders | — |
| Lipase increased | Investigations | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Pain | General disorders | — |
| White blood cell decreased | Investigations | — |
| Investigations - Other, specify | Investigations | — |
| Serum amylase increased | Investigations | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hyperthyroidism | Endocrine disorders | — |
| Infections and infestations - Other, specify | Infections and infestations | — |
| Neutrophil count decreased | Investigations | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Adrenal insufficiency, Diarrhea, Abdominal pain, Aspartate aminotransferase increased, Fatigue, Gastrointestinal disorders - Other, specify, Infections and infestations - Other, specify, Vomiting.
Data from ClinicalTrials.gov NCT03442569 adverse events section.
To investigate the combination of nivolumab and ipilimumab with panitumumab in subjects with unresectable, refractory, KRAS/NRAS/BRAF wild-type, microsatellite stable (MSS) metastatic colorectal cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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