Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer

NCT04030455 | Active Not Recruiting Phase 2 Results FDA Drug

• 2 other identifiers: 2018-0876NCI-2019-02750
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well cisplatin, docetaxel, and pembrolizumab work in treating patients with stage II-III laryngeal cancer. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cisplatin, docetaxel, and pembrolizumab may help to control the disease.

Conditions

Laryngeal Squamous Cell Carcinoma; Stage II Laryngeal Cancer AJCC v8; Stage III Laryngeal Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD)

  To determine the clinical benefit rate (CBR) of patients with stage II or III larynx squamous cell carcinoma (SCC) after 2 cycles of pembrolizumab, cisplatin and docetaxel (PCD), and the pathologic complete response (pCR) rate after 4 cycles of PCD. The CBR rate of patients with stage II or III larynx SCC after 2 cycles of PCD is 100%, excluding one patient (measurable data not available). The pCR rate after 4 cycles of PCD is 75.0%. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), diseappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter with an absolute increase of at least 5 mm or the appearance of new lesions

  CBR after 2 cycles (6 weeks), pCR after 4 cycles (12 weeks), end of study (up to 3 years)

Secondary Outcomes (5)

• Safety and Tolerability of PCD in Patients With Larynx SCC -- Number of Adverse Events

  first administration of investigational agent until 30 days following last dose of study drug; approximately 3 years and 11 months

• Larynx Preservation Rates for Overall and pCR Patients at 2 Years

  study registration to laryngectomy or date of censoring (2 years follow up)

• To Determine the 2-year Relapse-free Survival (RFS) and Overall Survival (OS) in the Overall Population and in the Subgroup Who Achieves a pCR (RFS)

  from first study registration to recurrence after local therapy or death from any cause (up to 2 years follow up)

• To Determine the 2-year Relapse-free Survival (RFS) and Overall Survival (OS) in the Overall Population and in the Subgroup Who Achieves a pCR. (OS)

  first study registration to death due to any cause or date of censuring (up to 2 years follow up)

• DIGEST

  baseline, 6 months post treatment, long-term follow up (up to two years)

Study Arms (1)

Treatment (cisplatin, docetaxel, pembrolizumab)

EXPERIMENTAL

Patients receive cisplatin IV over 1 hour, docetaxel IV over 1 hour (patients who develop significant adverse events to cisplatin treatment may receive carboplatin IV over 1 hour instead), and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who completely respond to the study drugs (the disease appears to go away) then receive pembrolizumab IV over 30 minutes on day 1 for 4 additional cycles in the absence of disease progression or unacceptable toxicity.

Drug: Carboplatin; Drug: Cisplatin; Drug: Docetaxel; Biological: Pembrolizumab

Interventions

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment (cisplatin, docetaxel, pembrolizumab)

Cisplatin DRUG

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone''s Chloride, Peyrone''s Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Treatment (cisplatin, docetaxel, pembrolizumab)

Docetaxel DRUG

Given IV

Also known as: Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

Treatment (cisplatin, docetaxel, pembrolizumab)

Pembrolizumab BIOLOGICAL

Given IV

Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475

Treatment (cisplatin, docetaxel, pembrolizumab)

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed, previously untreated, histologically confirmed stage II to III larynx squamous cell carcinoma will be enrolled in this study
• A male participant must agree to use a contraception during the treatment period and for at least 150 days after the last dose of study treatment and refrain from donating sperm during this period
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) OR
• A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 150 days after the last dose of study treatment
• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
• Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Have provided archival tumor tissue sample (minimum of 20 unstained slides) or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation
• Absolute neutrophil count (ANC) \>= 1500/ul (within 10 days prior to the start of study treatment)
• Platelets \>= 100000/ul (within 10 days prior to the start of study treatment)
• Hemoglobin \>= 9.0 g/DL or \>= 5.6 mmol/L (within 10 days prior to the start of study treatment) (criteria must be met without erythropoietin dependency and without packed red blood cell \[pRBC\] transfusion within last 2 weeks)
• Creatinine OR measured or calculated (creatinine clearance \[CrCl\] should be calculated per institutional standard) creatinine clearance (glomerular filtration rate \[GFR\]: can also be used in place of creatinine or CrCl): =\< 1.5 x ULN OR \>= 30 mL/min for participant with creatinine levels \> 1.5 x institutional upper limit of normal (ULN) (within 10 days prior to the start of study treatment)
• Total Bilirubin =\< 1.5 x ULN OR direct bilirubin =\< ULN for participants with total bilirubin level \> 1.5 x ULN (within 10 days prior to the start of study treatment)
• ALT (SGPT) = alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT) = aspartate aminotransferase (serum glutamic oxaloacetic transaminase); =\< 2.5 x ULN (=\< 5 X ULN for participants with liver metastases (within 10 days prior to the start of study treatment)

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply: a WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)
• Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment. Note: participants must have recovered from all adverse events (AEs) due to previous therapies to =\< grade 1 or baseline. Participants with =\< grade 2 neuropathy may be eligible. Note: if participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
• Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette - Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated vaccines and are not allowed
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug, with the exception of dexamethasone, that can be given the day prior (D0) until 4 days after chemotherapy (D4) up to 16 mg per day for prevention of chemotherapy-induced nausea, fluid retention, and/or allergic reaction
• Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: participants with basal or squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy, and prostate cancer patients in active surveillance are not excluded
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). 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 a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
• Has an active infection requiring intravenous antibiotics therapy
• Has a known history of human immunodeficiency virus (HIV)
• Has a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \< 615 IU/L) infection. Note: no testing for hepatitis B and hepatitis C is required unless mandated by local health authority
• Has a known history of active TB (Bacillus tuberculosis)
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Laryngeal Neoplasms

Interventions

Carboplatin; Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Docetaxel; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Renata Ferrarotto, MD
• Organization: The University of Texas MD Anderson Cancer Center

rferrarotto@mdanderson.org

(713) 745-6774

Study Officials

• Renata Ferrarotto

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: July 24, 2019
• Study Start: August 7, 2019
• Primary Completion: September 4, 2025
• Study Completion (Estimated): September 17, 2026
• Last Updated: March 9, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-03

Locations

US (1)