Nab-Paclitaxel in Combination With Nivolumab to Treat Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma That Progressed on a PD-1 or PD-L1 Inhibitor

NCT04831320 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 202105128
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The primary hypothesis is that the objective response rate (ORR) with nab-paclitaxel and nivolumab will be significantly higher than the historical control (ORR 30%). The KEY secondary hypothesis is that the median PFS with nab-paclitaxel and nivolumab will be significantly longer than the historical control (median PFS 3.6 months).

Conditions

Metastatic Head-and-neck Squamous-cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) as assessed by RECIST 1.1

  * ORR: Proportion of patients who achieve a complete or partial response to treatment * Complete Response (CR): Disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  Through completion of treatment (estimated to be 4 months)

Secondary Outcomes (11)

• Progression-free survival (PFS)

  Through completion of follow-up (estimated to be 13 months)

• Duration of response (DOR)

  Through completion of treatment (estimated to be 4 months)

• Incidence of adverse events

  Through 100 days after completion of treatment (estimated to be 7.5 months)

• Incidence of immune-related adverse events

  Through 100 days after completion of treatment (estimated to be 7.5 months)

• Number of dose reductions of nab-paclitaxel

  Through completion of treatment (estimated to be 4 months)

Study Arms (1)

nab-Paclitaxel + Nivolumab

EXPERIMENTAL

* nab-Paclitaxel 125 mg/m\^2 intravenous (IV) on days 1, 8 \& 15 of each 28-day cycle. * Nivolumab 480 mg IV Day 1 of each 28-day cycle.

Drug: nab-paclitaxel; Drug: Nivolumab

Interventions

nab-paclitaxel DRUG

Supplied by Celgene Corporation

Also known as: Abraxane

nab-Paclitaxel + Nivolumab

Nivolumab DRUG

Supplied by Bristol-Myers Squibb

Also known as: Opdivo

nab-Paclitaxel + Nivolumab

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed recurrent or metastatic HNSCC of the oral cavity, larynx, hypopharynx, oropharynx, or p16 positive neck node with unknown primary (but clinically thought to be oropharynx).
• Known p16 status (positive or negative) if oropharynx or unknown primary of the neck.
• Measurable disease per RECIST. Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
• Progression of disease, as assessed by RECIST, that occurred on a PD-1 or PD-L1 inhibitor (given alone or with other therapy) to treat recurrent or metastatic disease. Progression of disease that occurred on a PD-1 or PD-L1 inhibitor given as a component of a curative-intent regimen is excluded.
• PD-L1 CPS by IHC (22C3 antibody) on tumor tissue is strongly encouraged to be available or performed, although the test result is not required to enroll onto the trial. Patients with tumor PD-L1 TPS (but not CPS) available are also eligible; but, PD-L1 CPS should be performed in these cases. Fresh tumor tissue (obtained after progression on prior PD-1 or PD-L1 inhibitor given for recurrent or metastatic disease) is strongly preferred, but archived tumor tissue from recurrence or initial diagnosis is also acceptable.
• At least 18 years of age.
• ECOG performance status \< 1
• Normal bone marrow and organ function as defined below:
• Hemoglobin \> 9 g/L
• Absolute neutrophil count ≥ 1,500/mcl
• Platelets ≥ 100,000/mcl (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
• Total bilirubin ≤ 1.5 mg/dL
• AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (in cases of bone mets or liver mets, AST/ALT \< 5 x IULN)
• Serum creatinine \<1.5 x IULN or creatinine clearance \> 50 mL/min by Cockcroft-Gault
• The effects of nivolumab and nab-paclitaxel on the developing human fetus are unknown. For this reason and because monoclonal antibodies and antimicrotubule agents are known to be teratogenic, women of childbearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 6 months after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

You may not qualify if:

• A history of other malignancy with the exception of malignancies for which all treatment was completed at least 1 year before registration and the patient has no evidence of disease.
• Has known active CNS metastases. Subjects with previously treated brain metastases may participate provided they are stable (without any evidence of progression by imaging 4 weeks prior to the first dose of study treatment and any neurologic symptoms have stabilized), have no evidence of new or enlarging brain metastases, and are on stable or tapering doses of steroids for at least 14 days prior to first dose of study treatment.
• A history of serious allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study (Allergic reaction to cetuximab is allowed as there are other standard of care options for the investigator's choice arm).
• Greater than Grade 2 pre-existing peripheral neuropathy (per CTCAE).
• Uncontrolled serious intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the start of study treatment.
• Prior organ or allogeneic stem cell transplant.
• Has an active autoimmune disease (i.e. rheumatoid arthritis, lupus, Sjogren's syndrome) that has required IV or subcutaneous systemic treatment in the past 6 months (excluding Rituxan). Replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Prisoners, or subjects who are compulsory detained.
• Prior taxane (including paclitaxel or docetaxel) given to treat recurrent or metastatic disease.
• Prior taxane (including paclitaxel or docetaxel) given as a component of a curatively intended multimodality therapy IF the latter was completed within 6 months of subsequent development of recurrent or metastatic disease.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Douglas R Adkins, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

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: March 31, 2021
• First Posted: April 5, 2021
• Study Start: September 28, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)