Metastatic Head-and-neck Squamous-cell CarcinomaPhase 2NCT04831320
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
A Phase 2 study testing nab-paclitaxel and Nivolumab in people with Metastatic Head-and-neck Squamous-cell Carcinoma, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Head-and-neck Squamous-cell Carcinoma
- What is being tested?
- nab-paclitaxel and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2021to 31 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 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.
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- 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.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable) before the performance of any protocol-related procedures.
Who cannot join
- 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).
- Receiving systemic corticosteroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of treatment. A history of severe autoimmune disorder requiring high-dose corticosteroid treatment due to prior PD-1 inhibitor is an exclusion criterion.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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: A Single-Arm, Phase 2 Trial
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).
- Being tested
- nab-paclitaxel, Nivolumab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-paclitaxelDrug
Also called Abraxane
Supplied by Celgene Corporation
NivolumabDrug
Also called Opdivo
Supplied by Bristol-Myers Squibb
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: nab-paclitaxel; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through completion of treatment (estimated to be 4 months)
Secondary outcomes (11)
Progression-free survival (PFS)
- PFS, defined as the days from the date of treatment to the first documentation of disease progression or death from any cause, whichever occurs first. The alive patients without progression are censored at the date of last follow-up. The patients without progression will not receive anti-cancer therapy, but the patients who have progression may receive additional anti-cancer therapy.
- Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Measured: Through completion of follow-up (estimated to be 13 months)
Duration of response (DOR)
- Duration of overall response: The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
- Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level.
- Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Through completion of treatment (estimated to be 4 months)
Incidence of adverse events
Measured: Through 100 days after completion of treatment (estimated to be 7.5 months)
Incidence of immune-related adverse events
Measured: Through 100 days after completion of treatment (estimated to be 7.5 months)
Number of dose reductions of nab-paclitaxel
Measured: Through completion of treatment (estimated to be 4 months)
Number of dose reductions of nivolumab
Measured: Through completion of treatment (estimated to be 4 months)
Number of dose delays of nab-paclitaxel
Measured: Through completion of treatment (estimated to be 4 months)
Number of dose delays of nivolumab
Measured: Through completion of treatment (estimated to be 4 months)
Number of dose interruptions of nab-paclitaxel
Measured: Through completion of treatment (estimated to be 4 months)
Number of dose interruptions of nivolumab
Measured: Through completion of treatment (estimated to be 4 months)
Overall survival (OS)
-OS: defined as the days from the date of treatment to death from any cause, censored at the date of last follow-up otherwise.
Measured: Through completion of follow-up (estimated to be 13 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start28 Sep 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Head-and-neck Squamous-cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Douglas R Adkins, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831320
- Sponsor's protocol ID
- 202105128
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2021
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: A Single-Arm, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT04831320
- Acronym / sponsor ID
- 202105128
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-Paclitaxel + Nivolumab | Experimental | Drug: nab-paclitaxel, Drug: Nivolumab* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
- Receiving systemic corticosteroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of treatment. A history of severe autoimmune disorder requiring high-dose corticosteroid treatment due to prior PD-1 inhibitor is an exclusion criterion.
- Greater than Grade 2 pre-existing peripheral neuropathy (per CTCAE).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nab-paclitaxelAlso: AbraxaneSupplied by Celgene Corporation | Drug | nab-Paclitaxel + Nivolumab |
| NivolumabAlso: OpdivoSupplied by Bristol-Myers Squibb | Drug | nab-Paclitaxel + Nivolumab |
Primary outcome
Objective response rate (ORR) as assessed by RECIST 1.1
Time frame: Through completion of treatment (estimated to be 4 months)
* 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.
11 secondary outcomes
Progression-free survival (PFS)
Time frame: Through completion of follow-up (estimated to be 13 months)
Duration of response (DOR)
Time frame: Through completion of treatment (estimated to be 4 months)
Incidence of adverse events
Time frame: Through 100 days after completion of treatment (estimated to be 7.5 months)
Incidence of immune-related adverse events
Time frame: Through 100 days after completion of treatment (estimated to be 7.5 months)
Number of dose reductions of nab-paclitaxel
Time frame: Through completion of treatment (estimated to be 4 months)
Number of dose reductions of nivolumab
Time frame: Through completion of treatment (estimated to be 4 months)
Number of dose delays of nab-paclitaxel
Time frame: Through completion of treatment (estimated to be 4 months)
Number of dose delays of nivolumab
Time frame: Through completion of treatment (estimated to be 4 months)
Number of dose interruptions of nab-paclitaxel
Time frame: Through completion of treatment (estimated to be 4 months)
Number of dose interruptions of nivolumab
Time frame: Through completion of treatment (estimated to be 4 months)
Overall survival (OS)
Time frame: Through completion of follow-up (estimated to be 13 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas R Adkins, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nab-paclitaxel and Nivolumab in people with Metastatic Head-and-neck Squamous-cell Carcinoma, run by Washington University School of Medicine 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 12 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 6 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
Objective response rate (ORR) as assessed by RECIST 1.1 (time frame: Through completion of treatment (estimated to be 4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2026.