Pembrolizumab With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors

NCT03360890 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB17-0994
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II, 2-cohort, single arm trial treated with the combination of the following two agents:

1. 1.Pembrolizumab (MK3475) 200mg, every three weeks, iv
2. 2.Docetaxel 75mg/m2, every three weeks, iv

Conditions

Thyroid Cancer; Salivary Gland Cancer

Keywords

thyroid cancer; salivary gland cancer; pembrolizumab; docetaxel

Outcome Measures

Primary Outcomes (1)

• Rate of response

  From the start of treatment until the first documented record of response, up to 100 months, whichever comes first.

Secondary Outcomes (3)

• Number of adverse events

  Up to 24 months.

• Overall rate of survival

  From the start of treatment until the first record of death by any cause, up to 100 months, whichever comes first.

• Rate of progression free survival

  From the start of treatment to the first record of disease progression or death by any cause, up to 100 months, whichever comes first.

Study Arms (2)

Cohort 1: salivary gland tumors without SOC treatment option

EXPERIMENTAL

All patients will receive pembrolizumab and docetaxel. First pembrolizumab and docetaxel will be given together. After which patients will receive pembrolizumab alone until disease progression or up to 35 cycles (about 2 years).

Drug: Pembrolizumab; Drug: Docetaxel

Cohort 2: 'aggressive' thyroid cancer without SOC treatment op

EXPERIMENTAL

All patients will receive pembrolizumab and docetaxel. First pembrolizumab and docetaxel will be given together. After which patients will receive pembrolizumab alone until disease progression or up to 35 cycles (about 2 years).

Drug: Pembrolizumab; Drug: Docetaxel

Interventions

Pembrolizumab DRUG

Pembrolizumab will be administered via IV at 200mg every three weeks. Patients will receive pembrolizumab for about 2 years.

Also known as: Keytruda

Cohort 1: salivary gland tumors without SOC treatment option; Cohort 2: 'aggressive' thyroid cancer without SOC treatment op

Docetaxel DRUG

Docetaxel will be administered via IV at 75mg/m2 every three weeks for 3 to 6 cycles.

Also known as: taxotere

Cohort 1: salivary gland tumors without SOC treatment option; Cohort 2: 'aggressive' thyroid cancer without SOC treatment op

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed disease that is unresectable and not amenable to curative intent therapy:
• Cohort A: salivary gland cancers (mucoepidermoid carcinoma, adenocarcinoma, adenoidcystic carcinoma, acinic cell carcinoma, or other histology) originating in salivary glands.
• Cohort B: thyroid cancer, RAI-refractory and after failure, intolerance to or refusal of anti-antiangiogenic therapy, or with evidence of dedifferentiated or anaplastic histology.
• ECOG performance status 0 or 1.
• Consent to undergo on treatment biopsy if tumor is accessible and safe to biopsy
• Measurable disease per RECIST 1.1, bone only metastatic disease may be allowed on approval from study PI.
• Life expectancy of greater than 12 weeks.
• Available tissue for PD-L1 staining (archival or new core needle biopsy at baseline if no archival tissue available). A minimum of 10 slides are required (unless approval from the PI is obtained)
• Age greater than or equal to 18 years on day of signing informed consent.
• Demonstrate reasonable organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
• System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) Renal Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR Measured or calculateda creatinine clearance ≥40 mL/min for subject with creatinine levels \> 2.0 X (GFR can also be used in place of creatinine or CrCl) institutional ULN
• Hepatic Serum total bilirubin ≤ 1.2 X ULN OR in case of Gilbert's disease an elevated total Bilirubin is allowed if direct Bilirubin is ≤40% of total AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN
• Coagulation International Normalized Ratio (INR) or ≤1.5 X ULN unless subject is receiving anticoagulant therapy Prothrombin Time (PT) as long as PT or PTT is within therapeutic range of intended use of anticoagulants
• Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
• aCreatinine clearance should be calculated per institutional standard.

You may not qualify if:

• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose of treatment.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of prednisone 10mg/24h equivalent, or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Has a known history of active TB (Bacillus Tuberculosis)
• Has hypersensitivity to pembrolizumab, docetaxel or any of its excipients.
• Has had a prior anti-cancer monoclonal antibody (mAb) within 3 weeks prior to study Day 1, or targeted small molecule therapy within 2 weeks prior to study Day 1, or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier, with the exception of lymphopenia or asymptomatic aberrancies of sodium, amylase, lipase or alkaline phosphatase.
• Has not recovered from prior surgery, chemotherapy or radiation therapy from adverse events due to a previous treatment/administered agent (i.e., ≤ Grade 1 or return to baseline prior to treatment).
• Note: Subjects with ≤ Grade 2 neuropathy, any grade hearing loss or tinnitus, or typical side effects from radiotherapy are an exception to this criterion and may qualify for the study.
• Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical or other cancers that are not likely to influence life expectancy in the subsequent 3 years without active treatment (e.g. low grade prostate cancer in absence of therapy).
• Has known active (growing) central nervous system (CNS) metastases and/or carcinomatous meningitis. Prior radiation or resection is acceptable if clinically stable for at least 4 weeks.
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids in excess of prednisone 10mg/24h equivalent or immunosuppressive drugs) and would represent significant morbidity risk in judgement of investigator. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Has known history of, or any evidence of, active non-infectious pneumonitis.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Salivary Gland Neoplasms

Interventions

pembrolizumab; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Alexander Pearson

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 4, 2017
• Study Start: March 26, 2018
• Primary Completion: December 5, 2025
• Study Completion (Estimated): September 1, 2032
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)