Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer

NCT03172624 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 17-219
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to find out what effects, good and/or bad, treatment with two drugs called nivolumab and ipilimumab have on the participant and salivary cancer.

Conditions

Salivary Gland Cancer

Keywords

Nivolumab; Ipilimumab; 17-219

Outcome Measures

Primary Outcomes (1)

• Best Overall Response Rate

  using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)

  2 years

Study Arms (2)

R/M adenoid cystic carcinoma (ACC)

EXPERIMENTAL

Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).

Drug: Nivolumab; Drug: Ipilimumab

R/M SGC of any histology, except ACC (Non ACC)

EXPERIMENTAL

Enrolled patients will be treated with nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks).

Drug: Nivolumab; Drug: Ipilimumab

Interventions

Nivolumab DRUG

nivolumab 3 mg/kg every 2 weeks

R/M SGC of any histology, except ACC (Non ACC); R/M adenoid cystic carcinoma (ACC)

Ipilimumab DRUG

ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)

R/M SGC of any histology, except ACC (Non ACC); R/M adenoid cystic carcinoma (ACC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort 1 only: Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma. Cancers arising from non-salivary gland primary sites are allowed.
• Patients must have pathologically or cytologically confirmed salivary gland cancer of any histology except for adenoid cystic carcinoma.
• Patients must have recurrent and/or metastatic disease not amenable to potentially curative surgery or radiotherapy.
• At least 2 weeks must have elapsed since the end of prior systemic treatment and/or 4 weeks since completion of radiotherapy with resolution of all treatment-related toxicity to NCI CTCAE Version 4.0 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism) prior to starting study drug treatment. Any number of prior therapies for recurrent/metastatic salivary gland cancer are allowed.
• NOTE: Patients previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs prior to trials enrollment and concomitantly with study therapy.
• Patients must have RECIST v1.1 measurable disease.
• Cohort 1 and acinic cell carcinoma patients in Cohort 2 only: Patients must have documentation of a new or progressive lesion on a radiologic imaging study performed within 6 months prior to study enrollment (progression of disease over any interval is allowed) and/or new/worsening disease related symptoms within 6 months prior to study enrollment. Note: This assessment will be performed by the treating investigator. Evidence of progression by RECIST criteria is not required.
• Age ≥ 18 years.
• ECOG performance status 0 or 1 (or Karnofsky ≥ 70%).
• Patients must have tissue from the primary tumor or metastases available for correlative studies. Either a paraffin block or at least 20 unstained slides are acceptable (30 unstained slides would be ideal). (If less than twenty unstained slides are available and a paraffin bloc is not available, the patient may be able to participate at the discretion of the investigator.)
• Patients must agree to undergo two research biopsies of malignant lesions. Tumor tissue obtained prior to study consent or treatment as part of standard of care can also be submitted in lieu of performance of the first pre-treatment biopsy, if the Principal Investigator deems it to be of sufficient quantity/quality/timeliness. Patients may be exempt from biopsy if 1) the investigator or person performing the biopsy judges that no tumor is accessible for biopsy, 2) the investigator or person performing the biopsy feels that the biopsy poses too great of a risk to the patient, or 3) the patient's platelet count is \<100,000/mcl or he/she cannot be safely removed from anti-coagulation therapy (if the anti-coagulation therapy needs to be temporarily held for the biopsy procedure). If the only tumor accessible for biopsy is also the only lesion that can be used for RECIST v1.1 response evaluation, then the patient may be exempt from biopsy. If the investigator deems a second research biopsy to be high risk after a patient has completed the first research biopsy, the patient may be exempt from the second biopsy.
• Screening laboratory values must meet the following criteria:
• WBC ≥ 2000/μL
• Neutrophils ≥ 1500/μL
• Platelets ≥ 100 x10\^3/μL

You may not qualify if:

• Symptomatic metastatic brain or leptomeningeal tumors (asymptomatic or treated metastatic brain or leptomeningeal tumors are allowed).
• Current or prior use of immunosuppressive doses of systemic corticosteroids (\>10 mg/day prednisone equivalents) or other immunosuppressive medications within 2 weeks of study drug administration. NOTE: Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \>10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (eg, delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
• Active, known, or suspected autoimmune disease within the past 2 years. NOTE: Subjects are permitted to enroll if they have 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
• Patients should be excluded if they have had prior systemic treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
• Patients should be excluded if they have a known history of testing positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV antibody) indicating acute or chronic infection (those with treated hepatitis B or C infection and a negative viral load prior to study entry would be eligible)
• Patients should be excluded if they have a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
• History of allergy to study drug components.
• History of severe hypersensitivity reaction to any monoclonal antibody.
• Women who are pregnant or breast-feeding.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (8)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Publications (2)

• Vos JL, Burman B, Jain S, Fitzgerald CWR, Sherman EJ, Dunn LA, Fetten JV, Michel LS, Kriplani A, Ng KK, Eng J, Tchekmedyian V, Haque S, Katabi N, Kuo F, Han CY, Nadeem Z, Yang W, Makarov V, Srivastava RM, Ostrovnaya I, Prasad M, Zuur CL, Riaz N, Pfister DG, Klebanoff CA, Chan TA, Ho AL, Morris LGT. Nivolumab plus ipilimumab in advanced salivary gland cancer: a phase 2 trial. Nat Med. 2023 Dec;29(12):3077-3089. doi: 10.1038/s41591-023-02518-x. Epub 2023 Aug 24.

  PMID: 37620627 DERIVED

• Tchekmedyian V. Salivary Gland Cancers. Hematol Oncol Clin North Am. 2021 Oct;35(5):973-990. doi: 10.1016/j.hoc.2021.05.011.

  PMID: 34503735 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Alan Ho, MD, PhD
• Organization: Memorial Sloan Kettering Cancer Center

hoa@mskcc.org

646-888-4235

Study Officials

• Alan Ho, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase II study evaluating the efficacy of nivolumab in combination with ipilimumab in patients with recurrent and/or metastatic (R/M) salivary gland cancers (SGCs). Patients will be enrolled to two cohorts: Cohort 1, patients with R/M adenoid cystic carcinoma ("ACC group"), and Cohort 2: patients with R/M SGC of any histology, except ACC ("non-ACC group").

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 1, 2017
• Study Start: May 26, 2017
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2024-12

Locations

US (8)