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Laryngeal Squamous Cell CarcinomaPhase 2NCT04030455

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

A Phase 2 study testing Carboplatin, Cisplatin and Docetaxel in people with Laryngeal Squamous Cell Carcinoma and Stage II Laryngeal Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Cisplatin and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
7 Aug 2019to 17 Sep 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)
  • International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT): =< 1.5x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (within 10 days prior to the start of study treatment)

Who cannot join

  • 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
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  • 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
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 days after the last dose of trial treatment
  • Has had a solid organ transplant and/or allogenic bone marrow transplant

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Immuno-Chemotherapy as Single Treatment Modality for Larynx Preservation (ICoLP)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

SECONDARY OBJECTIVES:

  1. To determine safety and tolerability of PCD in patients with larynx SCC. II. To determine the laryngeal preservation rate (LPR) at 2 years in the overall population and in the subgroup who achieves a pCR.

III. 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.

IV. To determine patient-reported outcomes (PROs) using M. D. Anderson Symptom Inventory-Head and Neck (MDASI-HN) and swallow function using Dynamic Imaging Grade of Swallowing Toxicity (DIGEST).

EXPLORATORY OBJECTIVES:

  1. To assess predictive tissue and blood-based biomarkers of benefit from PCD in larynx SCC.

OUTLINE:

Patients receive cisplatin intravenously (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.

After completion of study treatment, patients are followed up at 3 weeks, then every 6-12 weeks for up to 2 years.

Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Laryngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • DocetaxelDrug

    Also called Docecad, RP56976, Taxotere, Taxotere Injection Concentrate

    Given IV

  • PembrolizumabBiological

    Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475

    Given IV

Study groups in NCT04030455
Study groupRoleWhat they receive
Treatment (cisplatin, docetaxel, pembrolizumab)ExperimentalPatients 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.
Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Docetaxel; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (5)

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

    Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines. All AEs, whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy

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

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

    To determine the laryngeal preservation rate (LPR) at 2 years in the overall population and in the subgroup who achieves a pCR. KM method was used. The larynx preservation rate is calculated by dividing the number of patients who did not need a laryngectomy (either total or partial) after initial treatment by the total number of patients who were candidates for such a treatment.

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

  3. 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)

    Relapse free survival is defined as the time from study registration to recurrence after local therapy or death from any cause. Recurrence was counted only if it occurred after definitive local therapy (surgery and/or radiotherapy). Patients achieving durable complete responses to PCD without local therapy, and patients receiving local therapy without subsequent recurrence, were censored at last follow-up.

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

  4. 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)

    Overall survival is defined from study registration to death due to any cause or to the date of censoring measure at the last contact. KM method was used.

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

  5. DIGEST

    To determine swallow function using Dynamic Imaging Grade of Swallowing Toxicity (DIGEST). DIGEST is a validated psychometric tool used during modified barium swallow studies (MBSSs) to grade swallowing safety, efficiency, and overall pharyngeal swallow function. Scores ranging from 0 to 4, where 0 indicates no impairment, 1=mild, 2=moderate, 3=severe, 4=life threatening. The DIGEST grade was collected at three time points: baseline, 6 months post-treatment and long-term follow-up. One subject without any DIGEST data was excluded from analysis. A linear mixed-effects model was used to evaluate the effects of treatment group (chemo-IO alone vs. radiation/surgery) and time on DIGEST grade across three time points.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2019
  2. Study start7 Aug 2019
  3. Primary completion4 Sep 2025
  4. Study completion17 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04030455
Sponsor's protocol ID
2018-0876
Other IDs
NCI-2019-02750, 2018-0876
Status last verified
Mar 2026
First submitted
13 Jun 2019
Last updated
9 Mar 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Cisplatin and Docetaxel in people with Laryngeal Squamous Cell Carcinoma and Stage II Laryngeal Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CBR (After 2 Cycles of PCD) AND pCR (After 4 Cycles of PCD) (time frame: CBR after 2 cycles (6 weeks), pCR after 4 cycles (12 weeks), end of study (up to 3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04030455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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