Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Carcinoma, Ductal

Disease Progression

Carcinoma, Adenoid Cystic

Salivary Gland Neoplasms

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Adenoid Cystic Carcinoma

Oral Cancer

cabozantinib tablets (Cabometyx®) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw for a maximum duration of 2 years.

Cabozantinib

Carla ML van Herpen, MD, PhD

Phase 2 clinical trial on the efficacy of cabozantinib in locally advanced, recurrent and/or metastatic salivary gland cancer patients.

Rationale: Salivary gland cancer (SGC) is a rare cancer with 24 histological subtypes. Treatment options for locally advanced and/or metastatic SGC are limited. The tyrosine kinase inhibitor cabozantinib suppresses tumor growth, angiogenesis, and metastasis, and has been approved for renal cell carcinoma and thyroid cancer. Cabozantinib may also be of value in advanced SGC because c-MET, one of the targets of cabozantinib, is frequently overexpressed in SGC.

Objectives: To assess the objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DoR), toxicity, and quality of life (QoL) of patients with advanced SGC treated with cabozantinib in 3 cohorts: salivary duct carcinoma (SDC), adenoid cystic carcinoma (ACC), other SGC's.

Study design: Single arm, single center, phase II clinical trial in 3 cohorts: ACC, SDC and other SGC's.

Study population: Patient with c-MET positive, locally advanced, recurrent, and/or metastatic SGC.

Intervention: Cabozantinib tablets 60 mg once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw for a maximum duration of 2 years.

3 cohorts:

* adenoid cystic carcinoma
* salivary duct carcinoma
* other subtypes of salivary gland cancer

sample size: The Simon two-stage design will be used, The first stage consists of 9 patients per cohort ((1) SDC, (2) ACC) evaluable for response. If 0 responses out of the first 9 evaluable patients are observed, the study will be stopped. In any other situation, the study will be continued until 17 patients are evaluable for response per cohort. If ≤2 responses are observed the study will accept the null hypothesis. If \>2 responses are observed, the null hypothesis will be rejected. In the third cohort (other SGC) 9 patients will be included to evaluate the efficacy of cabozantinib in other subtypes of c-MET positive SGC. Because different subtypes are included in this cohort, these results are hypothesis forming but will not be used for statistical analysis. Therefore, this study cohort will be closed after the first stage with 9 patients.

Cabozantinib in Advanced Salivary Gland Cancer Patients

The Efficacy of Cabozantinib in Advanced SAlivary Gland Cancer Patients, a Phase II Clinical Trial

Response will be measured according to RECIST version 1.1, the overall response rate is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient

progression free survival is defined as time from study enrollment until disease progression or death. Outcome will be scored as 'progressed' or 'censored' according to the FDA guidance for industry of clinical trial endpoints.

overall survival is defined as time from study enrollment until date of death of any cause. Analysis of OS will be done at the end of the study (study related follow-up will be until 3 years after start of treatment)

duration of response is defined as time from study enrollment until date of documented tumor progression or death. Only patients with a CR or PR will be included in the assessment of duration of response.

defined as the sum of complete remissions, partial responses, and patients with stable disease for \>6 months.

adverse events will be reported as descriptive statistics in a table

scale range 0-10, in which a higher score represents more pain

response rate depicted in a waterfall plot

circulating tumor DNA levels will be assessed to evaluate whether treatment response and disease progression can be predicted.

c-MET immunohistochemical score ranges from 0 to 300.

Ipsen

Radboud University Medical Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Urogenital Neoplasms

Prostatic Neoplasms, Castration-Resistant

Neoplasms by Histologic Type

Prostatic Diseases

Carcinoma, Acinar Cell

Genital Neoplasms, Male

Carcinoma, Mucoepidermoid

Mucoepidermoid Tumor

Neoplasms, Glandular and Epithelial

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Cystic, Mucinous, and Serous

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Acinic Cell Carcinoma

Mucoepidermoid Carcinoma

Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen A. Rimiducid may be administered as indicated.

Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen A. Rimiducid may be administered as indicated.

Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen B. Rimiducid may be administered as indicated.

Cyclic administration of ascending dose cohorts, given via intravenous infusions of CAR-T cells, following conditioning chemotherapy regimen B. Rimiducid may be administered as indicated.

P-PSMA-101 is an autologous chimeric antigen receptor (CAR) T-cell therapy designed to target prostate cancer cells expressing the cell surface antigen prostate-specific membrane antigen (PSMA).

P-PSMA-101 CAR-T cells

Rimiducid (safety switch activator) may be administered as indicated

Rimiducid

Rajesh Belani, M.D.

An open-label, multi-center, single and cyclic ascending dose study of P-PSMA-101 autologous CAR-T cells in patients with mCRPC and SGC.

This is an open label, multi-center Phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts of single and multiple doses of P-PSMA-101 to determine a Recommended Phase 2 Dose (RP2D). Additional participants will be treated with P-PSMA-101 at the determined RP2D.

Following consent, enrolled participants will undergo a leukapheresis procedure to obtain peripheral blood mononuclear cells (PBMCs) which will be sent to a manufacturing site to produce P-PSMA-101 CAR-T cells. The cells will then be returned to the investigational site and administered after a lymphodepleting chemotherapy regimen. Rimiducid may be administered as indicated.

Open label, 3 + 3 design of dose-escalating cohorts with open label, dose expansion at RP2D

P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)

A Phase 1 Dose Escalation and Expanded Cohort Study of P-PSMA-101 in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)

Incidence and severity of treatment-emergent adverse events

According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, secondarily Immune Response Evaluation Criteria in Solid Tumors (iRECIST), and Prostate Cancer Response assessed by Prostate Cancer Working Group 3 (PCWG3) criteria: Overall Response Rate (ORR)-Percentage of patients with complete response (CR) or partial response (PR).

Poseida Therapeutics, Inc.

Recurrence

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Goserelin

Androgen Antagonists

Bicalutamide

Dutasteride

Antineoplastic Agents, Hormonal

Hormones

Hormone Antagonists

5-alpha Reductase Inhibitors

Enzyme Inhibitors

Patients from cohort B (ADT-resistant) will receive CAB+dutasteride.

Goserelin injection (10.8 mg) once per 3 months until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.

Goserelin 10.8 mg

Bicalutamide tablets (50 mg) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.

Bicalutamide 50 mg

Dutasteride capsules (0.5 mg) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.

Dutasteride 0.5 mg

Jetty AM Weijers, MSc

Jack A Schalken, PhD

Gerald W Verhaegh, PhD

Carla van Herpen, MD, PhD

Phase 2 clinical trial on the addition of dutasteride to combined androgen blockade (CAB) therapy in recurrent and/or metastatic (R/M) salivary duct carcinoma (SDC) patients.

The study included two cohorts of patients: Cohort A, which comprises ADT-naïve patients, and Cohort B, which comprises ADT-resistant patients.

Cohort A is closed for inclusion as of April 18, 2024.

A prospective, randomized controlled, single-institution, phase II clinical trial to assess the objective response rate (ORR), duration of response (DoR), progression free survival (PFS), overall survival (OS), toxicity, quality of life (QoL), and expression of molecular targets of patients with R/M SDC treated with either combined androgen blockade (CAB; goserelin + bicalutamide) or CAB + dutasteride, Participants in Cohort A will be randomized 1:1 at the study entry to receive CAB (goserelin 10.8 mg/3months + bicalutamide 50 mg/once daily) or CAB + dutasteride (0.5 mg/once daily). Participants will receive treatment until until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw.

Cohort A is closed for inclusion as of April 18, 2024.

Patients will be included into two cohorts based on their previous treatments, either ADT-naïve (cohort A) or ADT-resistant patients (cohort B). In cohort A, the randomization will result in the allocation of the control arm (goserelin and bicalutamide) and experimental arm (goserelin, bicalutamide, and dutasteride) in a 1:1 ratio. In cohort B, patients ADT-resistant will be enrolled receiving similar therapy to the experimental arm, i.e. goserelin, bicalutamide, and dutasteride.

Cohort A is closed for inclusion as of April 18, 2024.

Phase II Dutasteride in Combination With CAB vs CAB in SDC

A Randomized Phase II Trial on the Addition of Dutasteride to Combined Androgen Blockade Therapy Versus Combined Androgen Blockade Therapy Alone in Patients With Recurrent and/or Metastatic Salivary Duct Carcinoma - DUCT Study

Response will be measured according to RECIST version 1.1, the ORR is defined as the sum of the complete remissions plus partial responses. The best response will be used in each patient.

Response will be measured according to RECIST version 1.1, the DoR is defined as the time from first tumor assessment at which the overall response was recorded as partial response (PR) or complete response (CR) that is subsequently confirmed until documented progressive disease (PD) or death form any cause, whichever occurs first.

Response will be measured according to RECIST version 1.1, the PFS is defined as the time from study enrolment until date of first documented disease progression or death due to any cause, whichever occurs first.Every 12 weeks a CT/MRI scan will be made to asses the progression free survival until PD.

Response will be measured according to RECIST version 1.1, the CBR is defined as the confirmed CR or PR at any time or stable disease (SD) of at least 6 months. Every 12 weeks a CT/MRI scan will be made to asses the clinical benefit rate until PD.

The OS is defined as the time from study enrolment to the date of death to any cause.

Quality of Life (QoL) based on the EORTC QLQ-C30 questionnaire. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD.

Quality of Life (QoL) based on the EORTC QLQ-H\&N43 questionnaire. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD.

Quality of Life (QoL) based on the EORTC QLQ-SHQ22 questionnaire. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD.

Scale range 0-10, in which a higher score represents more pain. Participants are asked to fill in the questionnaires in week 0 (before start of treatment, baseline), every 12 weeks, and at PD.

Adverse events will be recorded using International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, the investigator will assess whether those events are drug related. Every OPD visit (every 3 months until PD)

ctDNA levels will be assessed to evaluate whether treatment response and disease progression can be predicted. Baseline, 3 months, 6 months, and at PD.

mRNA expression of AR and AR splice variants on baseline and post-treatment tumor tissue samples to evaluate whether treatment response and disease progression can be predicted. Pre-treatment and post-treatment (i.e. PD)

mRNA expression of SRD5A1/SRD5A2 on baseline and post-treatment tumor tissue samples to evaluate whether treatment response and disease progression can be predicted. Pre-treatment and post-treatment (i.e. PD)

ZonMw: The Netherlands Organisation for Health Research and Development

D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks

nanoxel

herzuma

Myung-Ju Ahn, PhD

1. Study outline This is a multicenter, single-arm, phase II trial to evaluate the efficacy and safety of nanoxel plus herzuma combination chemotherapy in patients with metastatic salivary ductal cancer. Approximately 41 patients will be enrolled. Treatment will be continued until disease progression or unacceptable toxicities. Response evaluation will be performed every 2 cycles.
2. Dosing \& Treatment schedule D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks (In case of discontinuation of nanoxel without progression, single agent herzuma can be administered until progression)

Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma

Combination of Nanoxel and Herzuma as First-line Chemotherapy in Patients With Metastatic Salivary Duct Carcinoma : Open Label Single Arm Multicenter Phase II Study

Samsung Medical Center

Professor

Drug: Lutetium-177-PSMA-I\&T, 4 cycles of 7.4 GBq intravenously, every 6 weeks.

4 cycles of 7.4 GBq 177Lu-PSMA every 6 weeks.

Lutetium-177-PSMA-I&T

Phase 2 pilot study, which evaluates the safety and efficacy of Lutetium-177-PSMA radioligand therapy in advanced salivary gland cancer patients.

Rationale: Prostate specific membrane antigen (PSMA) is a transmembrane protein, which is expressed on prostate cancers cells and other malignancies. Recently, several ligands have been developed that target PSMA. Linked to Gallium-68, this enables diagnostic 68Ga-PSMA-PET/CT scans. Linked to Lutetium-177 enables therapeutic 177Lu-PSMA Radioligand therapy. Most research on the diagnostic and therapeutic possibilities of PSMA has been conducted in patients with advanced prostate cancer.

This research group investigates whether these findings also apply to salivary gland cancer (SGC), a rare cancer. Previously the investigators conducted a phase II 68Ga-PSMA imaging study (NCT03319641), to evaluate PSMA ligand uptake in locally advanced, recurrent and metastatic (R/M) ACC and SDC (two subtypes of SGC). A relevant PSMA-ligand uptake was observed in 93% of ACC patients and 40% of SDC patients. Therefore we consider 177Lu-PSMA radioligand therapy a potential new treatment option for these subtypes of SGC.

Objective: To evaluate the safety and efficacy of 177Lu-PSMA RLT in patients with R/M ACC and SDC with PSMA ligand uptake.

Study design: Phase II pilot study, single centre, two cohorts.

Phase II pilot study, single centre, two cohorts. Cohort 1: Patients with R/M ACC Cohort 2: Patients with R/M SDC

Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients

Lutetium-177-PSMA Radioligand Therapy for Advanced Salivary Gland Cancer, a Phase II Pilot Study.

Response will be measured according to RECIST version 1.1

PFS will be defined as time from study enrollment until disease progression or death.

OS will be defined as time from study enrollment until date of death of any cause.

Only patients with complete remission or partial response will be included in the assessment of DoR. DoR is defined as time from study enrollment until disease progression or death

QoL will be assessed using EORTC QLQ-C30 questionnaire. This is the core questionnaire for assessing health related quality of life of cancer patients participating in clinical trials. It contains 30 items and incorporates a global health status scale, five functional scales, three symptom scales, and several single items assessing additional symptoms. All of the scales and single-item measures range from 0-100. A high score for global health status represents a high QoL, a high score in functional scale represents a high/healthy level of functioning, a high score for a symptom scale/item represents a high level of symptomatology/problems.

QoL will be assessed using EORTC QLQ-H\&N43 questionnaire. This is an additional questionnaire to assess health related topics relevant for head and neck cancer patients. The module contains 43 questions, all symtom scales or symptom items.All of the scale/item measures range from 0-100. For all scales/items higher scores indicate more problems.

QoL will be assessed using performance status scale for head\&neck cancer patients (PSS-HN). It contains 3 items, each randing from 0-100. These items are rated by the health professional. A high score indicates a high performance status.

QoL will be assessed using pain visual analogue scale (VAS) questionnaire. This include two questions: the average pain during the past week and the worst pain during the past week. Both questions range from 0-100, a higher score indicates more pain.

Delivered doses will be calculated based on pharmacokinetics in the blood and dosimetry on SPECT/CT imaging.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cabozantinib in Advanced Salivary Gland Cancer Patients	NCT03729297	Salivary Gland ...	Cabozantinib	18 Years -	Radboud University Medical Center
P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)	NCT04249947	Prostatic Neopl... Neoplasms by Hi... Neoplasms, Pros... Prostate Cancer Metastatic Cast... Neoplasms Prostatic Neopl... Genital Neoplas... Urogenital Neop... Neoplasms by Si... Prostatic Disea... Salivary Gland ... Salivary Gland ... Adenoid Cystic ... Salivary Duct C... Mucoepidermoid ... Acinic Cell Tum...	P-PSMA-101 CAR-... Rimiducid	18 Years -	Poseida Therapeutics, Inc.
Phase II Dutasteride in Combination With CAB vs CAB in SDC	NCT05513365	Salivary Duct C...	Goserelin 10.8 ... Bicalutamide 50... Dutasteride 0.5...	18 Years -	Radboud University Medical Center
Cabozantinib in Advanced Salivary Gland Cancer Patients	NCT03729297	Salivary Gland ...	Cabozantinib	18 Years -	Radboud University Medical Center
Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma	NCT03614364	Salivary Duct C...	nanoxel herzuma	20 Years -	Samsung Medical Center
Phase II Dutasteride in Combination With CAB vs CAB in SDC	NCT05513365	Salivary Duct C...	Goserelin 10.8 ... Bicalutamide 50... Dutasteride 0.5...	18 Years -	Radboud University Medical Center
Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients	NCT04291300	Salivary Gland ... Salivary Duct C... Adenoid Cystic ...	Lutetium-177-PS...	18 Years -	Radboud University Medical Center

Spots Global Cancer Trial Database for salivary duct carcinoma