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Primary Objective: - To determine the feasibility of administering E7 TCR-T cell therapy as induction treatment for LAHPVC Secondary Objectives: - To determine the objective tumor response rate at 6-weeks after treatment - To assess 2-year and 5-year disease free survival (DFS) - To collect biospecimens for exploratory translational research
Protocol Number: 192104
Principal Investigator: Christian Hinrichs
Phase: Phase I
Scope: Local
Applicable Disease Sites: Breast ,Cervix ,Lip, Oral Cavity and Pharynx ,Other Female Genital ,Other Male Genital ,Stomach
Therapies Involved: Immunotherapy
Drugs Involved: TCR-T Cell infusion
Read Inclusion & Exclusion Criteria
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.
Primary: - To assess anti-tumor activity of amivantamab monotherapy in participants with R/M HNSCC who have received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. Secondary: - To further assess anti-tumor activity of amivantamab monotherapy in participants with R/M HNSCC who have received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor - To characterize safety and tolerability of amivantamab monotherapy in participants with R/M HNSCC who have received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. - To characterize PK of amivantamab monotherapy in participants with R/M HNSCC who have received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.
Protocol Number: 032405
Principal Investigator: Missak Haigentz
Phase: Phase I/II
Scope: National
Applicable Disease Sites: Lip, Oral Cavity and Pharynx
Therapies Involved: Chemotherapy multiple agents systemic Chemotherapy single agent systemic
Drugs Involved: Amivantamab CARBOPLATIN PACLITAXEL Pembrolizumab (MK-3475)
The primary objective of this trial is to determine the objective tumor response rate (CR+PR) and duration of response for treatment of recurrent/refractory or metastatic HPV-associated cancers with E7 TCR-T cells.
Protocol Number: 192204
Phase: Phase II
Applicable Disease Sites: Anus ,Cervix ,Larynx ,Lip, Oral Cavity and Pharynx ,Other Female Genital ,Other Male Genital
Drugs Involved: E7 TCR T cell
Primary Objective: To identify biomarkers for cancer pain in biofluids and tissue of cancer patients with pain, compared to cancer patients without pain or patients with non malignant tumors, or normal patients. Secondary Objective: To identify epigenetic and gene expression biomarkers in tissues or biofluids that could differentiate between cancer, pre-cancer and normal/non malignancy patients.
Protocol Number: 032202
Phase: N/A
Primary Objectives: -To determine the MTD and recommended Phase 2 dose (RP2D) of ipatasertib in combination with definitive chemoradiation in locally advanced head and neck squamous cell carcinoma (HNSCC) based on dose-limiting toxicities (DLTs). Secondary Objectives: - To assess acute and late toxicities, based on CTCAE version 5.0. Toxicities occurring >90 days from the end of radiation therapy will be considered late toxicities. - To assess long-term swallowing function, based on gastric tube dependency at 6 and 12 months that is different from baseline. - To determine duration and completion rate of prescribed radiation and chemotherapy. - To determine pharmacokinetic profile of ipatasertib in combination with cisplatin and radiation therapy, based on peak and trough blood levels in patients administered ipatasertib orally. - To determine pharmacodynamic effects of ipatasertib at the MTD, based on pAKT, pS6 and pPRAS40 as markers of AKT pathway inhibition, and gamma-H2AX as a marker of radiosensitization. - To observe and record anti-tumor activity (objective response rate by RECIST criteria, locoregional control, relapse-free survival, and overall survival) of the combination of ipatasertib, cisplatin, and radiation therapy in patients with HNSCC. Although the clinical benefit of this combination has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. - To correlate efficacy outcomes with tumor genotype, based on whole exome sequencing of pre-treatment biopsy specimens.
Protocol Number: 032204
Applicable Disease Sites: Larynx ,Lip, Oral Cavity and Pharynx
Therapies Involved: Chemotherapy single agent systemic Radiotherapy
Drugs Involved: Ipatasertib
Primary objective: - To evaluate the disease-free survival (DFS) of patients with stage III-IV SCCHN and disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin. Secondary objective(s): - To evaluate the DFS of patients with stage III-IV SCCHN and non-disruptive p53 mutations after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin - To evaluate the DFS of patients with stage III-IV SCCHN and p53 wild type after primary surgical resection followed by PORT alone or PORT with concurrent cisplatin - To evaluate toxicities of PORT alone or PORT with concurrent cisplatin. - To evaluate p53 mutation as a predictive biomarker of survival benefit given post-operative concurrent radiation and cisplatin. - To identify potential genomic alterations in addition to TP53 mutations that may be developed to a novel treatment approach.
Protocol Number: 032402
Principal Investigator: Taha Mur
Phase II Component Primary Objective: To select the better docetaxel-based experimental arm to improve disease-free survival (DFS) over the control arm of radiation and cisplatin. *Phase II Component is complete and the docetaxel-cetuximab arm has advanced to Phase III; please continue to Phase III Component. Phase III Component Primary Objectives: 1. To determine if the combination of docetaxel-cetuximab and IMRT is superior in terms of overall survival (OS) compared to standard cisplatin and IMRT in the adjuvant treatment of pathologic high risk, HPV-negative HNSCC. 2. To determine if the combination of atezolizumab, cisplatin, and IMRT is superior in terms of OS compared to standard cisplatin and IMRT in the adjuvant treatment of pathologic high risk, HPV negative HNSCC.
Protocol Number: 032403
Phase: Phase II/III
Therapies Involved: Chemotherapy multiple agents systemic Radiotherapy
Drugs Involved: Atezolizumab (MPDL3280A) CETUXIMAB CISPLATIN DOCETAXEL