Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
351 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-07-07
Study Completion Date
2022-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Recurrent and/or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) are a common clinical situation and although this group of patients has very heterogeneous disease characteristics, they share a dismal prognosis with a median survival time around 6-11 months and a relatively poor quality of life.
Immunotherapy approaches have recently demonstrated clinical efficacy in more than twenty cancer types, including melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC) and SCCHN. Nivolumab demonstrated significant overall survival benefit as treatment for recurrent SCCHN in a randomized phase III Study CA209141 conducted on a cohort of 361 patients (240 in the nivolumab arm and 121 in the standard therapy arm), presenting this condition and whose disease had progressed within 6 months after platinum-based chemotherapy. In this study, treatment with nivolumab resulted in significantly longer survival than treatment with standard therapy with a median overall survival of 7.5 months vs 5.1 months (p=0.01).
The main objective of the study is to provide additional insight into the frequency of high-grade AEs related to nivolumab and their outcome, and thus supplement the growing safety database of nivolumab-treated recurrent and/or metastatic squamous cell carcinoma of the head and neck patients.
Immunotherapy approaches have recently demonstrated clinical efficacy in more than twenty cancer types, including melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC) and SCCHN. Nivolumab demonstrated significant overall survival benefit as treatment for recurrent SCCHN in a randomized phase III Study CA209141 conducted on a cohort of 361 patients (240 in the nivolumab arm and 121 in the standard therapy arm), presenting this condition and whose disease had progressed within 6 months after platinum-based chemotherapy. In this study, treatment with nivolumab resulted in significantly longer survival than treatment with standard therapy with a median overall survival of 7.5 months vs 5.1 months (p=0.01).
The main objective of the study is to provide additional insight into the frequency of high-grade AEs related to nivolumab and their outcome, and thus supplement the growing safety database of nivolumab-treated recurrent and/or metastatic squamous cell carcinoma of the head and neck patients.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Nivolumab in Patients With Head and Neck Cancer.
NCT04050761
Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck
COMPLETED
Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
NCT03349710
Squamous Cell Carcinoma of the Head and Neck
COMPLETED
PHASE3
Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
NCT03370276
Squamous Cell Carcinoma of the Oropharynx
Squamous Cell Carcinoma of the Larynx
Squamous Cell Carcinoma of the Oral Cavity
+5 more
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
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
NCT02823574
Head and Neck Cancer
COMPLETED
PHASE2
NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy SCCHN
NCT05802290
Squamous Cell Carcinoma of Head and Neck
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Recurrent and/or Metastatic Platinum-refractory SCCHN
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nivolumab
All patients enrolled in the study will received Nivolumab injections, 3mg/kg IV, every 2 weeks, up to 12 cycles (1 cycle = 28 days).
Group Type
EXPERIMENTAL
Nivolumab Injection
Intervention Type
DRUG
Nivolumab 3 mg/kg, every 2 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nivolumab Injection
Nivolumab 3 mg/kg, every 2 weeks
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Adult men and women ≥18 years.
2. Histologically confirmed recurrent and/or metastatic SCCHN (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
3. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
4. Documentation of p16-positive or p16-negative disease to determine human papillomavirus (HPV) status of tumor for SCC of the oropharynx.
5. Tumor progression or recurrence after a platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting. In the adjuvant or primary setting, the recurrence must have occurred within 6 months after the last dose of platinum therapy. Clinical progression after platinum therapy is an allowable event for entry and is defined as progression of a lesion at least 10 mm in size that is amenable to caliper measurement (eg superficial skin lesion as per RECIST v1.1) or a lesion that has been visualized and photographically recorded with measurements and shown to have progressed.
6. Measurable disease by CT or MRI per RECIST v1.1.
7. Prior curative radiation therapy must have been completed at least 4 weeks prior to study drug administration. Prior focal palliative radiotherapy must have been completed at least 2 weeks before study drug administration.
8. Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses \> 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration.
9. Patients with brain metastases will be eligible if they are: asymptomatic, without edema, not on corticosteroids, have been treated and there is no magnetic resonance imaging (except where contraindicated in which CT scan is acceptable) evidence of progression for at least 4 weeks after treatment is complete.
10. Screening laboratory values must meet the following criteria (using CTCAE v4) and should be obtained within 7 days prior to the first study drug administration :
1. White blood cell (WBC) ≥2000/μL.
2. Polynuclear neutrophils ≥1.5 x 10⁹/L.
3. Platelets ≥75 x 10⁹/L.
4. Hemoglobin \>8.0 g/mL.
5. Alanine aminotransferase (ALAT)/aspartate transaminase (ASAT) ≤3.0 x upper limit of normal (ULN) in the absence of liver metastases or ≤5 x ULN in the presence of liver metastases.
6. Total Bilirubin ≤1.5 x ULN (except Gilbert Syndrome : \<3.0 mg/dL)
7. Creatinine clearance ≥40 mL/min (measured or calculated by Cockcroft and Gault formula) or serum creatinine \<2.0 x ULN.
11. Calcium levels must be normalized and maintained within normal limits for study entry and on treatment. Medical management of calcium levels is permitted. Note: Normal calcium levels may be based on ionized calcium or adjusted for albumin.
12. Subjects with an initial magnesium \<0.5 mmol/L (1.2 mg/dL) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (eg, magnesium oxide) at the investigator's discretion.
13. Potentially reproductive patients must agree to use an effective contraceptive method or practice adequate methods of birth control or practice complete abstinence, 14 days before starting study drug and while on treatment, and for at least 31 weeks (≈ 7 months) for males and 23 weeks (≈ 5 months) for females after the last dose of study drug. Azoospermic males and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements.
14. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 24 hours prior to the first dosing.
15. Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose.
16. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
17. Patients with social insurance coverage.
1. Histologically confirmed recurrent and/or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg mucosal melanoma) are not allowed.
2. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
3. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
4. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
5. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first study drug administration. Inhaled or topical steroids and adrenal replacement doses \>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
6. Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
7. Patients receiving anti-cancer therapies must be discontinued at least 2 weeks prior to administration of study drug. Palliative, focal radiation therapy, and immunosuppressive doses of systemic corticosteroids, except replacement organotherapy (hydrocortisone and fludrocortisone), must be discontinued at least 2 weeks before administration of study drug.
8. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug. Subjects with toxicities attributed to systemic prior anticancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll.
9. Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
10. Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
11. Use of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to study drug. The use of the inactivated seasonal influenza vaccine (Fluzone®) is allowed.
12. Known or underlying medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or adverse events.
13. History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake (if applicable).
14. Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study.
15. Individuals deprived of liberty or placed under the authority of a tutor.
16. Treatment with any other investigational agent, or participation in another clinical trial within 28 days, prior to first study drug administration and during the treatment period.
17. Known history or active symptomatic interstitial lung disease.
18. History of organ transplantation or allogeneic stem cells transplantation .
19. Severe infection requiring parenteral antibiotics treatment.
20. Active tuberculosis.
2. Histologically confirmed recurrent and/or metastatic SCCHN (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
3. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
4. Documentation of p16-positive or p16-negative disease to determine human papillomavirus (HPV) status of tumor for SCC of the oropharynx.
5. Tumor progression or recurrence after a platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting. In the adjuvant or primary setting, the recurrence must have occurred within 6 months after the last dose of platinum therapy. Clinical progression after platinum therapy is an allowable event for entry and is defined as progression of a lesion at least 10 mm in size that is amenable to caliper measurement (eg superficial skin lesion as per RECIST v1.1) or a lesion that has been visualized and photographically recorded with measurements and shown to have progressed.
6. Measurable disease by CT or MRI per RECIST v1.1.
7. Prior curative radiation therapy must have been completed at least 4 weeks prior to study drug administration. Prior focal palliative radiotherapy must have been completed at least 2 weeks before study drug administration.
8. Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses \> 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration.
9. Patients with brain metastases will be eligible if they are: asymptomatic, without edema, not on corticosteroids, have been treated and there is no magnetic resonance imaging (except where contraindicated in which CT scan is acceptable) evidence of progression for at least 4 weeks after treatment is complete.
10. Screening laboratory values must meet the following criteria (using CTCAE v4) and should be obtained within 7 days prior to the first study drug administration :
1. White blood cell (WBC) ≥2000/μL.
2. Polynuclear neutrophils ≥1.5 x 10⁹/L.
3. Platelets ≥75 x 10⁹/L.
4. Hemoglobin \>8.0 g/mL.
5. Alanine aminotransferase (ALAT)/aspartate transaminase (ASAT) ≤3.0 x upper limit of normal (ULN) in the absence of liver metastases or ≤5 x ULN in the presence of liver metastases.
6. Total Bilirubin ≤1.5 x ULN (except Gilbert Syndrome : \<3.0 mg/dL)
7. Creatinine clearance ≥40 mL/min (measured or calculated by Cockcroft and Gault formula) or serum creatinine \<2.0 x ULN.
11. Calcium levels must be normalized and maintained within normal limits for study entry and on treatment. Medical management of calcium levels is permitted. Note: Normal calcium levels may be based on ionized calcium or adjusted for albumin.
12. Subjects with an initial magnesium \<0.5 mmol/L (1.2 mg/dL) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (eg, magnesium oxide) at the investigator's discretion.
13. Potentially reproductive patients must agree to use an effective contraceptive method or practice adequate methods of birth control or practice complete abstinence, 14 days before starting study drug and while on treatment, and for at least 31 weeks (≈ 7 months) for males and 23 weeks (≈ 5 months) for females after the last dose of study drug. Azoospermic males and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements.
14. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 24 hours prior to the first dosing.
15. Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose.
16. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
17. Patients with social insurance coverage.
1. Histologically confirmed recurrent and/or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg mucosal melanoma) are not allowed.
2. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
3. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
4. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
5. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first study drug administration. Inhaled or topical steroids and adrenal replacement doses \>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
6. Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
7. Patients receiving anti-cancer therapies must be discontinued at least 2 weeks prior to administration of study drug. Palliative, focal radiation therapy, and immunosuppressive doses of systemic corticosteroids, except replacement organotherapy (hydrocortisone and fludrocortisone), must be discontinued at least 2 weeks before administration of study drug.
8. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug. Subjects with toxicities attributed to systemic prior anticancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll.
9. Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
10. Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
11. Use of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to study drug. The use of the inactivated seasonal influenza vaccine (Fluzone®) is allowed.
12. Known or underlying medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or adverse events.
13. History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake (if applicable).
14. Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study.
15. Individuals deprived of liberty or placed under the authority of a tutor.
16. Treatment with any other investigational agent, or participation in another clinical trial within 28 days, prior to first study drug administration and during the treatment period.
17. Known history or active symptomatic interstitial lung disease.
18. History of organ transplantation or allogeneic stem cells transplantation .
19. Severe infection requiring parenteral antibiotics treatment.
20. Active tuberculosis.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Sponsor Role
collaborator
UNICANCER
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Caroline Even, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy Cancer Campus - Villejuif
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut de Cancérologie de l'Ouest
Angers, , France
Site Status
CHU Bordeaux
Bordeaux, , France
Site Status
Centre Francois Baclesse
Caen, , France
Site Status
Centre Jean Perrin
Clermont-Ferrand, , France
Site Status
Centre Georges Francois Leclerc
Dijon, , France
Site Status
Centre Oscar Lambret
Lille, , France
Site Status
Centre Léon Bérard
Lyon, , France
Site Status
ICM Val d'Aurelle
Montpellier, , France
Site Status
Centre Antoine Lacassagne
Nice, , France
Site Status
Hopital Tenon
Paris, , France
Site Status
Institut Curie
Paris, , France
Site Status
Institut Jean Godinot
Reims, , France
Site Status
Centre Eugène Marquis
Rennes, , France
Site Status
Institut Curie Saint Cloud
Saint-Cloud, , France
Site Status
Centre Paul Strauss
Strasbourg, , France
Site Status
Institut Claudius Regaud
Toulouse, , France
Site Status
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Site Status
Gustave Roussy
Villejuif, , France
Site Status
Countries
Review the countries where the study has at least one active or historical site.
France
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-000424-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UC-0130/1703
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Observational Study of Nivolumab in Participants in Germany With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After Platinum-Based Therapy
NCT03114163
COMPLETED
Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT02741570
COMPLETED
PHASE3
A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)
NCT05068609
COMPLETED
A Study for Identification of Immune Determinants for Response to Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
NCT04603248
UNKNOWN
NA
Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in SCCHN
NCT03341936
ACTIVE_NOT_RECRUITING
PHASE2
Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN
NCT05743270
WITHDRAWN
PHASE2
Personalized Immunotherapy in Patients With Recurrent /Metastatic SCCHN That Have Progressed on Prior Immunotherapy
NCT04326257
COMPLETED
PHASE2
Predictive Biomarkers for Response to Nivolumab in Head and Neck Squamous Cell Carcinoma
NCT03652142
UNKNOWN
Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy
NCT03655444
TERMINATED
PHASE1/PHASE2
A Trial Evaluating the Addition of Nivolumab to Cisplatin-RT for Treatment of Cancers of the Head and Neck
NCT03576417
ACTIVE_NOT_RECRUITING
PHASE3
Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck
NCT03132038
COMPLETED
PHASE2
Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN
NCT03878979
COMPLETED
PHASE2
Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers
NCT05835804
NOT_YET_RECRUITING
PHASE2
Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
NCT02105636
COMPLETED
PHASE3
Decitabine and Nivolumab in Participants With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT07216833
NOT_YET_RECRUITING
PHASE1
An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck
NCT03386838
WITHDRAWN
PHASE3
Effectiveness and Safety of Nivolumab in Participants That Have Head and Neck Cancer That Has Come Back or Has Spread
NCT03569436
COMPLETED
Nivolumab Plus Gemcitabine in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma-HN17-11
NCT06440187
COMPLETED
PHASE2
Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC
NCT03646461
ACTIVE_NOT_RECRUITING
PHASE2
Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC
NCT05057247
COMPLETED
PHASE2
Pembrolizumab + Radiation for Locally Adv SCC of the Head and Neck (SCCHN) Not Eligible Cisplatin
NCT02609503
COMPLETED
PHASE2
Safety Testing of Adding Nivolumab to Chemotherapy in Patients With Intermediate and High-Risk Local-Regionally Advanced Head and Neck Cancer
NCT02764593
COMPLETED
PHASE1
Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery
NCT03342911
COMPLETED
PHASE2
Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma
NCT06308913
RECRUITING
EARLY_PHASE1
Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck
NCT03854032
ACTIVE_NOT_RECRUITING
PHASE2