Immunotherapy drug may delay cancer's return after surgery
NCT ID NCT02769520
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the immunotherapy drug pembrolizumab can help people with head and neck cancer that has come back after initial treatment. After surgery to remove the recurrent tumor, participants receive pembrolizumab to see if it extends the time before the cancer returns again. The trial enrolled 27 adults and tracks how long they remain cancer-free and any side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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27 people
The number who actually took part.
- Started
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Jul 2016
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Has pathologically confirmed SCCHN (oral cavity, oropharynx, larynx, hypopharynx) with evidence of local and/or locoregional recurrence. Laryngeal tumors will only be included if there is evidence of extralaryngeal spread, or there is associated nodal disease. For all other sites, superficial tumors can only be included if there is associated nodal disease. * Has a documented disease-free interval (minimum 16 weeks) after initial curative intent therapy. * Candidate for salvage resection. * Able to provide tissue from diagnostic core biopsy of tumor lesion(s). * Patient has adequate organ function. * Female patient of childbearing potential has a negative serum or urine pregnancy within 72 hours prior to receiving the first dose of study medication. * Female patient of childbearing potential agrees to use adequate birth control. * Male patient with a partner of childbearing potential agrees to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria: * Patient has disease of nasopharyngeal carcinoma histology. * Patient has evidence of metastatic disease. * Patient is currently receiving or has received another investigational agent within 4 weeks prior to study Day 1. * Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab. * Patient has a known history of active TB (Bacillus Tuberculosis). * Patient has received a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or baseline) from adverse events due to a previously administered agents. * Patient has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1. * Patients who have had major surgery or have insufficient recovery from surgical-related trauma or wound healing within 14 days from study Day 1. * Patient 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 cancer. * Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * Patient has an 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). Notes: (1) Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded. (2) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Patient has a known history of, or any evidence of active, non-infectious pneumonitis. * Patient receives chronic steroid use \> 10 mg prednisone (or steroid equivalent) daily. * Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial. * Patient has received immunotherapy with inhibitors of PD-1 or PD-L1, or CTLA-4 blocking antibodies within 4 months prior to study Day 1. * Patient has known active Hepatitis B infection (defined as presence of HepB sAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier (HIV 1/2 antibodies). * Patient has interstitial lung disease. * Patient is an appropriate candidate for adjuvant radiation after salvage therapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UCSD Moores Cancer Center
La Jolla, California, 92093, United States
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University of California Los Angeles
Torrance, California, 90505, United States
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University of California San Francisco
San Francisco, California, 94115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can Pre-Surgery immunotherapy prime the immune system to fight head and neck cancer?
- Can a new drug boost the power of chemoradiation against head and neck cancer?
- Experimental antibody combo aims to boost immune attack on head and neck tumors