Head & Neck Cancer Trials
Every treatment that has ever made a difference in cancer care was once a part of a clinical trial. MUSC Hollings Cancer Center is committed to offering the best treatments available today while searching for even better ones for the future. Ask your doctor if a clinical trial is right for you.
STUDY17022
First in Human, Phase 1/1b, Open label, Multicenter Study of Bifunctional EGFR/TGF ß Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients with EGFR Driven Advanced Solid Tumors
The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.
Study InformationSTUDY19284
Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.
Study InformationSTUDY21479
UF-HN-004 Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma based on HPV subtype and plasma circulating free HPV DNA Level and Clearance Rate.
To determine if Risk-Adapted De-Intensification of RT and chemotherapy based on HPV subtype, cfHPV DNA level, and cfHPV DNA clearance rate produces LRC rates that are similar to what has been achieved with more aggressive therapy in patients with for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma. To assess the 2-year clinical outcomes of local control (LC), regional control (LRC), disease-free survival (DFS), distant metastasis-free survival (DMFS), and overall survival (OS) in all treated patients. To evaluate the potential value of cfHPV DNA level after treatment to detect residual or recurrent cancer. To evaluate head and neck quality of life assessments before, during, and after RT in all treated patients. To evaluate speech and swallowing function after RT in all treated patients.
Study InformationSTUDY22304
A CONTROLLED, RANDOMIZED PHASE II TRIAL OF DOCETAXEL PLUS TRASTUZUMAB VERSUS ADO-TRASTUZUMAB EMTANSINE FOR RECURRENT, METASTATIC, OR TREATMENT-NAVE, UNRESECTABLE HER2-POSITIVE SALIVARY GLAND CANCER
To determine if trastuzumab emtansine (ado-trastuzumab emtansine [T-DM1]) shows better progression-free survival (PFS) when compared to docetaxel plus trastuzumab (TH) in recurrent and/or metastatic (R/M) HER2-positive salivary gland cancer (SGC) patients who have not previously received HER2 therapy for unresectable or recurrent and/or metastatic disease, as determined by local assessment.
Study InformationSTUDY23278
Phase 3 Study of Ficlatuzumab in Combination with Cetuximab in Subjects with Recurrent or Metastatic (R/M) HPV-Negative Head and Neck Squamous Cell Carcinoma (FIERCE-HN)
To compare the efficacy by overall survival of ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). To evaluate additional endpoints of efficacy for ficlatuzumab plus cetuximab vs placebo plus cetuximab in participants with R/M HNSCC.
Study InformationSTUDY23524
A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
To identify optimal biological dose by assessing safety and tolerability of ficerafusp alfa in subjects randomized to ficerafusap alpha 1500 mg once weekly with pembrolizumab (treatment arm A) and ficerafusp alfa 750 mg QW pembrolizumab. Assessing antitumor activity of ficerafusp alfa in subjects randomized to ficerafusp alfa 1500 mg QW with pembrolizumab (treatment Arm A) and ficerafusp alfa 750 mg QW and pembrolizumab (treatment Arm B).
Study InformationSTUDY23771
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to evaluate Dostarlimab as Sequential Therapy after Chemoradiation in Participants with Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma
To evaluate the efficacy of dostarlimab as sequential therapy following CRT as compared to placebo in participants with PD-L1 positive LA unresected HNSCC as per BICR. To estimate the difference in overall survival (OS) for participants treated with dostarlimab as sequential therapy following CRT as compared to placebo in participants with LA unresected HNSCC.
Study InformationSTUDY23849
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD and/or RP2D. Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1311 as monotherapy.
Study InformationSTUDY23968
A Multicenter, Open-Label Phase 1/1B Dose-Finding, Safety, and Pharmacokinetic Study of MBRC-101, an Anti-EPHA5 Monomethyl Auristatin E (MMAE) Antibody Drug Conjugate, in Advanced Refractory Solid Tumors
To identify potential OBRD and dosing regimens of MBRC-101. To establish the MTD of MBRC-101 using 1 or more dosing regimens. To identify potential RP2Ds and regimens of MBRC-101. To evaluate the safety of MBRC-101 at potential OBRDs, RP2Ds, and dosing regimens. To evaluate preliminary clinical activity of MBRC-101.
Study InformationSTUDY23972
Randomized Phase 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Patients With Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy
To determine if the progression-free survival (PFS) of the triplet combination (CaboNivoIpi) is more favorable than the doublet (NivoIpi). To compare safety and tolerability between the two arms (CTCAE v5.0.). To compare overall response rate (ORR) between the two arms via both RECIST v1.1 and iRECIST criteria. To compare overall survival (OS) between the two arms.To assess response by primary or acquired PD-1/L1 inhibitor resistance in the prior line of therapy.
Study Information