Phase 2
Completed N=425
Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Source: ClinicalTrials.gov NCT02823574 ↗Enrolled (actual)
425
Serious AEs
66.0%
Results posted
Apr 2022
Primary outcomePrimary: Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup — 13.2; 18.3 percentage of participants — p=0.2897
Summary
A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup |
13.2; 18.3 | 0.2897 |
| PRIMARY Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup |
NA; 11.07 | — |
| PRIMARY Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup |
2.56; 1.51 | — |
| SECONDARY Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup |
20.3; 29.5 | — |
| SECONDARY Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup |
27.04; 24.61 | — |
| SECONDARY Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup |
2.50; 2.60 | — |
| SECONDARY Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup |
2.76; 2.86 | — |
| SECONDARY Overall Survival (OS) |
9.76; 11.30 | — |
| SECONDARY Overall Survival (OS) - Platinum Refractory Subgroup |
9.76; 9.59 | — |
| SECONDARY Overall Survival (OS) - Platinum Eligible Subgroup |
9.71; 12.91 | — |
| SECONDARY ORR - Platinum Eligible Subgroup Based on HPV p-16 Status |
20.0; 41.2; 20.5; 25.0 | — |
| SECONDARY ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker |
10.2; 30.8; 34.2; 28.6; 17.3; 28.6 | — |
| SECONDARY ORR - Platinum Refractory Subgroup Based on HPV p-16 Status |
23.3; 37.5; 12.4; 16.7 | — |
| SECONDARY ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker |
9.0; 20.5; 23.3; 19.0; 11.0; 22.4 | — |
| SECONDARY Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status |
NA; 11.10; 39.43; 8.34 | — |
| SECONDARY Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status |
NA; 11.14; 38.67; 8.59; NA; 11.14 | — |
| SECONDARY Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status |
4.11; 6.70; 1.84; 1.94 | — |
| SECONDARY Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status |
1.45; 2.50; 2.76; 1.54; 1.68; 2.50 | — |
| SECONDARY Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status |
13.93; 14.32; 9.36; 9.59 | — |
| SECONDARY Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status |
5.78; 8.77; 11.37; 7.16; 7.52; 8.31 | — |
| SECONDARY Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status |
16.66; 33.74; 7.79; 9.46 | — |
| SECONDARY Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status |
7.56; 18.27; 16.30; 13.08; 9.99; 15.01 | — |
| SECONDARY Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status |
2.63; 2.92; 5.82; 2.83; 2.63; 2.99 | — |
| SECONDARY Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status |
2.92; 6.83; 2.66; 2.83 | — |
| SECONDARY Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status |
33.84; 48.49; 27.04; 19.32 | — |
| SECONDARY Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status |
10.97; NA; 24.11; 19.32; 13.67; NA | — |
| SECONDARY Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status |
39.43; 8.34; 39.43; 11.10; NA; 8.34 | — |
| SECONDARY ORR - Platinum Refractory Subgroup Based on PD-L1 Expression |
7.7; 25.8; 19.6; 19.6; 11.1; 21.1 | — |
| SECONDARY Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status |
9.53; 12.29; 10.22; 9.02; 9.95; 8.77 | — |
| SECONDARY Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status |
2.60; 2.96; 2.60; 2.60; 2.60; 2.79 | — |
| SECONDARY Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status |
33.84; 24.61; 13.17; 12.42; NA; NA | — |
| SECONDARY ORR - Platinum Eligible Subgroup Based on PD-L1 Expression |
15.7; 21.7; 21.5; 30.3; 14.9; 24.3 | — |
| SECONDARY Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status |
12.52; 11.17; 7.56; 14.00; 8.72; 11.17 | — |
| SECONDARY Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status |
2.61; 2.73; 2.89; 2.99; 2.37; 2.76 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed squamous cell head and neck cancer
- Widespread (metastatic) disease, or returned after previous treatment (recurrent)
- Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV [Human Papilloma Virus (oropharynx only)]
- Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)
Exclusion Criteria
- Previous treatment for metastatic or recurrent disease
- Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
- Any non-squamous subtype
- Active autoimmune disease
- Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus
- Previous treatment with checkpoint inhibitor drugs
- Active CNS metastases or carcinomatous meningitis
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02823574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.