Phase 2 N=425 Randomized Double-blind Treatment

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

Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02823574 ↗

Enrolled (actual)

425

Serious AEs

66.0%

Results posted

Apr 2022

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Nivolumab (Biological); Ipilimumab (Biological); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Jan 2019

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	—

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)

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

View full record on ClinicalTrials.gov →

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.