Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Peritoneal Neoplasms

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Nivolumab

Ipilimumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients will be treated with nivolumab plus standard of care dose dense paclitaxel and carboplatin for three cycles, where each cycle is 3 weeks, followed by cytoreductive surgery then three more cycles of the same treatment regimen administered as adjuvant treatment. Paclitaxel 80mg/m2 will be administered over approximately 1 hour as an IV infusion on Days 1,8, and 15 of each 21-day cycle. Carboplatin AUC6 will be administered as approximately a 30 minute IV infusion, following paclitaxel administration on Day 1 of each 21-day cycle. Carboplatin dose calculation instructions can be found in Appendix 4. Nivolumab 360mg will be infused IV over approximately 30min on Day 1 of Cycles 1-6. During the maintenance phase, Nivolumab 480mg will be infused IV on day 1 of each 28 day cycle, for up to 12 months. During the maintenance period, each cycle is 4 weeks.

Patients will be treated with nivolumab plus ipilimumab plus standard of care dose dense paclitaxel \& carboplatin chemotherapy for 3 cycles (up to a maximum of six), each cycle is 3 weeks, followed by cytoreductive surgery then three more cycles of the same treatment regimen. Paclitaxel 80mg/m2 IV will be administered over approx 1 hour on Days 1,8, \& 15 of each 21 day cycle. Carboplatin AUC6 will be administered as an approx 30 minute IV infusion, following paclitaxel admin on Day 1 of each 21 day cycle. Nivolumab 360mg will be infused IV over approx 30 min on Day 1 of Cycles 1-6 (to 9) of each 21 day cycle. Ipilimumab 1mg/kg will be infused IV over approx 30 min on Day 1 of Cycles 1 \& 3, as well as Cycle 4 \& Cycle 6. Of note, if patients receive more than 3 cycles in the pre-operative setting, then ipilimumab will be administered with the first \& third cycle in the post-operative setting. Nivolumab will then be infused Day 1 of each 28 day maintenance phase cycle.

Paclitaxel 80mg/m2 will be administered over approximately 1 hour as an IV infusion on Days 1,8, and 15 of each 21-day cycle. Carboplatin AUC6 will be administered as approximately a 30 minute IV infusion, following paclitaxel administration on Day 1 of each 21-day cycle.

Carboplatin and Paclitaxel

Nivolumab 360mg will be infused IV over approximately 30 min on Day 1 of Cycles 1-6 (to 8) of each 21 day cycle. During the maintenance phase, Nivolumab 480mg will be infused IV over approximately 30 min on day 1 of each 28 day cycle, for up to 12 months. During the maintenance period, each cycle is 4 weeks

Cytoreductive surgery

Ipilimumab 1mg/kg every 6 weeks x 3-6 cycles in the neoadjuvant setting (maximum 2 doses of ipilimumab)

Claire Friedman

The purpose of this study is to find out what effects, good or bad, the addition of nivolumab or the combination of nivolumab plus ipilimumab to typical chemotherapy has on the treatment of advanced high-grade serous cancers of ovarian, fallopian tube, or primary peritoneal origin. The typical chemotherapy treatment is Carboplatin and Paclitaxel.

Single center, non-randomized, open label, pilot study to evaluate the safety and tolerability of neoadjuvant and post-surgical dose dense paclitaxel and carboplatin chemotherapy in combination with nivolumab for the treatment of advanced high grade serous cancers of ovarian, fallopian tube, or primary peritoneal origin.

A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab With or Without Ipilimumab in Patients With Ovarian Cancer

A Pilot Study of Nivolumab With or Without Ipilimumab in Combination With Front-Line Neoadjuvant Dose Dense Paclitaxel and Carboplatin Chemotherapy and Post-Surgical Dose Dense Paclitaxel and Carboplatin Chemotherapy in Patients With High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The safety of this regimen will be assessed by determination of the DLTs observed in the study population. If \>=3/10 DLTs are seen we will deem the regimen not safe and stop the trial early. If \>=5/20 patients have DLTs the treatment regimen would be deemed unsafe. Enrollment will be halted after 10 patients have accrued until all 10 patients have cleared the DLT period of 6 weeks

Bristol-Myers Squibb

Memorial Sloan Kettering Cancer Center

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Week 1 : Cycle 1: Full Dose Carboplatin and Paclitaxel Week 4: Pelvic Radiotherapy Begins Cycle 2: Dose reduced Carboplatin and Paclitaxel Week 7 : Cycle 3: Dose reduced Carboplatin and Paclitaxel Weeks 10,13,16: Cycle 4-6: Full Dose Carboplatin and Paclitaxel

Regimen I: Carboplatin AUC 6 \& Paclitaxel 175mg/m2 given intravenously for 4 cycles during weeks 1, 10, 13, 16 Regimen II: Carboplatin AUC 2 \& Paclitaxel 45mg/m2 given intravenously for 2 cycles during weeks 4 \& 7 concurrent with radiotherapy

An external beam radiation dose of 45 Gy in 25 fractions is routinely prescribed to the Planning Target Volume (PTV) for postoperative radiotherapy.

The Vaginal Brachytherapy (VBT) Boost will be delivered after the external beam radiation. Doses of 12-18 Gy in 2-3 fractions are often prescribed to the surface of the vagina to a treatment length of 3-5 cm. There is no standard dose or fractionation schedule, so this dose, fractionation, location of dose specification , and length of vagina treated will be individualized for the patient and will be at the discretion of the treating radiation oncologist.

Radiation Therapy

Matthew Harkenrider, MD

The purpose of this trial is to evaluate the safety of sequential and concurrent carboplatin and paclitaxel with adjuvant external beam radiotherapy for locally advanced endometrial cancer. The primary objective is to assess the acute toxicities namely grade 3-4 non hematologic and grade 4 hematologic toxicities associated with the above regimen. The null hypothesis is that the unacceptable toxic response rate is ≥40%. This will be tested against a one-sided alternative that the toxicity rate is 20% or less. Simon's two-stage design was used to power this aim. In the first stage, 11 patients will be accrued. If there are 5 or more toxic responses in these 11 patients, the study will be stopped for safety reasons. Otherwise, 13 additional patients will be accrued for a total of 24 patients. Under these conditions, the probability of stopping early is 47% if the toxic response rate is truly higher than 20.0%. If this regimen is safe then its efficacy can be studied in a Phase III study.

Endometrial cancer is the most common gynecologic malignancy in the United States. Risk factors for development of endometrial cancer include increasing age, early menarche, late menopause, nulliparity, obesity, use of unopposed estrogen, and Lynch syndrome. The most common histology is endometrioid type adenocarcinoma, but less common, high-risk histologies include serous carcinoma, clear cell carcinoma, and carcinosarcoma. High risk stage I-II disease includes those with high risk histologies or any histology with multiple high risk features including deep myometrial invasion, high grade, and presence of extensive lymphovascular invasion. Locally advanced risk disease is routinely classified as Stage III-IVA. Despite treatment with adjuvant radiotherapy, chemotherapy, or combination radiotherapy and chemotherapy, relapse-free survival rates are 58-75% in modern series of GOG 258 and PORTEC-3. Therefore, there is significant need for improved therapies and optimization of combination therapy to improve these outcomes.

Standard initial management of endometrial cancer is total hysterectomy, bilateral salpingo-oophorectomy, and peritoneal washings with or without pelvic and paraaortic lymph node dissection. Endometrial cancer is surgically staged according the International Federation of Gynecologic Oncology (FIGO). Endometrioid type carcinomas most commonly present in an early stage, and several studies have established risk factors for recurrence including increasing depth of myometrial invasion, high grade, lymphovascular space invasion (LVSI), older age, greater tumor size, and increasing stage.

Historically, the rationale behind including adjuvant chemotherapy, either simultaneously with radiation therapy or sequentially, was the high rate of distant metastases despite lower pelvic failure rates with adjuvant radiation. The combination of chemotherapy and radiation therapy has additionally been shown to have greater survival compared either modality as monotherapy.

This study is designed to test the safety of adjuvant chemotherapy and radiotherapy with a novel regimen that addresses several of the hypotheses regarding the differing rate of distant metastases in GOG 258 while still using radiotherapy due to the locoregional control benefit from PORTEC-3.

To the knowledge of the investigators, no prospective study has reported on sequential and concurrent carboplatin and paclitaxel with EBRT for surgically managed endometrial cancer patients. With expeditious initiation of high dose systemic therapy and use of platinum/taxane combination chemotherapy concurrent with radiotherapy, we can address several potential hypotheses regarding the role that chemotherapy has to decrease the risk of distant metastases. Our primary objective is to assess the acute toxicities associated with sequential and concurrent carboplatin and paclitaxel with EBRT in the adjuvant management of endometrial cancer patients. If this regimen is safe, then its efficacy can be studied in a Phase III study.

This study will include high risk early stage and locally advanced endometrial cancer patients who are surgically managed with total or radical hysterectomy. Patients will be included if combination radiation therapy and chemotherapy is recommended. The most common patients to be enrolled Endometrioid type FIGO Stage I-II with high risk features, IIIC1 \& IVA OR Serous Carcinoma, Clear Cell Carcinoma, Carcinosarcoma Stage I-IIIC1 \& IVA

Adjuvant Sequential & Concurrent CarboTaxol + Radiotherapy for High Risk Endometrial Cancer

Phase II Study of Concurrent and Sequential Carboplatin and Paclitaxel With Adjuvant Radiotherapy for High Risk Endometrial Cancer

The primary outcome will be the number of Grade 3-4 acute non-hematologic and grade 4 hematologic toxicities associated with sequential and concurrent carboplatin and paclitaxel with EBRT in the adjuvant management of endometrial cancer patients as described in CTCAE version 5.0. These toxicities will be assess during the on treatment visits by the radiation and medical oncologist. If there are 5 or more toxic responses in the first 11 patients the study will be stopped for safety reasons.

To assess the number treatment delays in scheduled therapy \> 3 weeks associated with sequential and concurrent carboplatin and paclitaxel with EBRT in the adjuvant management of endometrial cancer patients.

To assess chronic toxicities associated with sequential and concurrent carboplatin and paclitaxel with EBRT in the adjuvant management of endometrial cancer patients.

To evaluate the disease specific outcome of local control associated with sequential and concurrent carboplatin and paclitaxel with EBRT in the adjuvant management of endometrial cancer patients. These endpoints will be assessed clinically and radiographically.

To evaluate the disease specific outcome of pelvic failure-free survival associated with sequential and concurrent carboplatin and paclitaxel with EBRT in the adjuvant management of endometrial cancer patients. These endpoints will be assessed clinically and radiographically.

To evaluate the disease specific outcome of distant metastasis-free survival associated with sequential and concurrent carboplatin and paclitaxel with EBRT in the adjuvant management of endometrial cancer patients. These endpoints will be assessed clinically and radiographically.

To evaluate the disease specific outcome of disease-free survival associated with sequential and concurrent carboplatin and paclitaxel with EBRT in the adjuvant management of endometrial cancer patients. These endpoints will be assessed clinically and radiographically.

To evaluate the disease specific outcome of cause-specific survival associated with sequential and concurrent carboplatin and paclitaxel with EBRT in the adjuvant management of endometrial cancer patients. These endpoints will be assessed clinically and radiographically.

To evaluate the outcome of overall survival associated with sequential and concurrent carboplatin and paclitaxel with EBRT in the adjuvant management of endometrial cancer patients. These endpoints will be assessed clinically and radiographically.

Loyola University

Associate Professor and Medical Director Radiation Oncology

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Jens B. Sorensen, MD

Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC (IB, IIA, IIB, and IIIA/N2).

Randomisation between 3 courses of neoadjuvant Carboplatin plus Paclitaxel or no chemotherapy before surgery.

Neoadjuvant Chemotherapy in Non Small Cell Lung Cancer (NSCLC) Stages IB, IIA, IIB, and IIIA/T3

Neoadjuvant Chemotherapy in Resectable NSCLC Stages IB, IIA, IIB, and IIIA/T3 But Not IIIA/N2

Rigshospitalet, Denmark

Bexarotene

bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.

bexarotene with carboplatin and paclitaxel

carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks.

carboplatin and paclitaxel

Mack Mabry, M.D.

This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

This study evaluates the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.

Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Eisai Inc.

Eisai, Inc

Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.

Bexarotene With Carboplatin and Paclitaxel

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or Not Reported

Counts are correct as reported. The BL measure title of "race" does not include counts of Hispanic or Latino population- which are reported in the BL measure title of "Ethnicity."

Race (NIH/OMB)

Eisai, Inc.

Overall Survival

Overall Study

postoperative 6 courses of 3 weekly iv carboplatin-paclitaxel combination chemotherapy

6 courses of iv 3-weekly chemotherapy Carboplatin AUC5 Paclitaxel 175mg/m2

observation

Mansoor R Mirza, MD

Patients with stage 1 \& 2 endometrial cancer are treated with surgery. Despite the fact that disease is confound to uterus, unfortunately some of these patients may relapse and die of their disease. Postoperative radiotherapy cannot improve survival. Chemotherapy has shown survival benefit in more advanced stage disease (stage 3 \& 4).

This study evaluates if one can improve survival in intermediate and high risk early-stage patients by offering them postoperative chemotherapy. This is a randomized phase 3 trial where effect of postoperative chemotherapy is compared with postoperative observation alone (standard strategy).

Substudy: Translational research

Patients with medium and high risk stage I and II endometrial cancers have, despite radical surgery, a rather high risk for progression.

Adjuvant radiotherapy was the traditional therapy for many decades. Four randomized phase III studies and a meta-analysis have revealed that adjuvant radiotherapy improves local control at the cost of excessive short and long term toxicity, though has absolutely no impact on survival.

Two phase III studies have randomized between adjuvant radiotherapy versus adjuvant chemotherapy, both failed to show any difference in survival between radiotherapy and chemotherapy, though both studies are criticized for inferior chemotherapy regimens or inclusion of good prognosis patients. The GOG-122 study on more advanced cases (stage 3 \& 4) randomized between combination chemotherapy versus whole abdominal irradiation and found significant improvement in survival in the chemotherapy arm.

NSGO-EC-9501 and MaNGO studies have indicated that adjuvant chemotherapy added to adjuvant radiotherapy may improve survival compared to adjuvant radiotherapy alone in early stage medium and high risk patients. One may conclude that impact on survival comes only from chemotherapy. Many investigators have therefore adapted adjuvant chemotherapy as standard treatment in various countries including Denmark. However, such conclusion has low level of evidence, as there are no randomized phase III studies comparing postoperative observation alone versus adjuvant chemotherapy.

It is of utmost importance to demonstrate efficacy of adjuvant combination chemotherapy in a randomized phase III trial comparing to no further treatment in the medium and high risk node negative stage 1 \& 2 patients.

Combination chemotherapy regimen of paclitaxel-carboplatin is proposed in this study, as this combination is effective and well tolerated.

The eligible patients for such a study are a fraction of patients with endometrial cancer therefore this study will be performed within the ENGOT collaboration.

Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer

A Phase II Randomized Trial of Postoperative Chemotherapy or no Further Treatment for Patients With Node-negative Stage I-II Intermediate or High Risk Endometrial Cancer

To detect an overall absolute difference in five-year survival of 10%, from 72% to 82%, at the 2.5% level with 80% power, 135 deaths corresponding to 644 patients are needed. Assuming a dropout rate of 5%, 678 patients have to be accrued, leaving 644 patients for the overall analysis.

In the endometrioid subgroup an absolute difference in five-year survival of 12%, from 74% to 86% is expected. Assuming this, 79 deaths corresponding to 438 patients are needed to yield 80% power at the 2.5% level. Assuming a dropout rate of 5%, 678 patients have to be accrued, leaving 644 patients for the overall analysis and 75% of these, or 483 patients, for the analysis in the endometrioid subgroup.

Acute toxicity (0-6 months from randomization). Late toxicity is registered during whole study period. Exploratory endpoint

European Organisation for Research and Treatment of Cancer - EORTC

Arbeitsgemeinschaft Gynaekologische Onkologie Austria

North Eastern German Society of Gynaecological Oncology

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Belgian Gynaecological Oncology Group

Mario Negri Gynecologic Oncology group (MaNGO)

Israeli Society of Gynecologic Oncology

Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITO)

Central and Eastern European Oncology Group

Danish Gynecological Cancer Group

Concurrent carboplatin and paclitaxel and IMPT (Intensity Modulated Proton Therapy)

carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist)

whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions

pelvic IMPT (Intensity Modulated Proton Therapy)

Pranshu Mohindra, MD

Ermiece Straub, MS

Ermiece Straub

Pilar Strycula

A phase 2 study with the primary objective of testing treatment compliance of Upfront Intensity Modulated Proton Beam Therapy (IMPT) and Concurrent Chemotherapy (UPPROACH) for Post-operative Treatment in Loco-regionally Advanced Endometrial Cancer is non-inferior to the historic compliance rate of the chemoradiation arm of GOG 258 study

While there is a consensus that both adjuvant ChT and RT benefit patients with respect to locoregional and distant control, the sequencing of these therapies varies between institutions. Common approaches include sequential treatment, with 4-6 cycles of ChT followed by RT, sandwich therapy with RT sandwiched between 3 cycles of ChT, or concurrent CRT. Small retrospective studies have shown a benefit with respect to PFS and OS in the sandwich approach, however this has not been replicated in larger studies.

In more recent years, proton beam therapy (PBT) has become an increasingly common modality for the treatment of uterine malignancies and is capable of even more precise dose distributions than photon-based RT due to intrinsic properties of these much heavier particles. Dosimetric/planning studies from other institutions confirm the significant reduction of dose to critical normal tissues like bladder, bowel, rectum, and bone marrow.

Preliminary data from the University of Maryland Medical Center has suggested that IMPT using pencil beam scanning is feasible in patients with endometrial cancer, with only 10% of patients developing grade 2 GI toxicity and no patients developing ≥ grade 3 GI or GU toxicities (abstract under review).

The investigators would like to test the hypothesis that in the postoperative setting, patients with advanced endometrial cancer will be able to complete a course of full dose ChT - carboplatin and paclitaxel - concurrent with upfront pelvic IMPT.

The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach

The "Upproach" Approach: A Phase 2 Study Of Upfront Intensity Modulated Proton Beam Therapy (Impt) And Concurrent Chemotherapy For Post-Operative Treatment In Loco-Regionally Advanced Endometrial Cancer

This will be measured as proportion of patients completing full 6 cycles of chemotherapy concurrently with IMPT

Measured by CTCAE (Common Terminology Criteria for Adverse Events)

Measured by PRO-CTCAE (Patient reported outcomes Common Terminology Criteria for Adverse Events)

Measured by EPIC (Expanded Prostate Cancer Index Composite ) bowel and urinary domain

University of Maryland, Baltimore

Principal Investigator

Symptoms and General Pathology

Immune System Diseases

Recurrence

Hypersensitivity

Fallopian Tube Neoplasms

Adnexal Diseases

Fallopian Tube Diseases

Fallopian Tube Cancer

Anti-Infective Agents

Gemcitabine

Sulfamethazine

Antimetabolites

Subjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week.

Subjects assigned to Arm II Gemcitabine and Latin Neople every week based on the first day of the outpatient / inpatient treatment receive it. The subjects first received Gemcitabine given over 30 minutes followed by 30 minutes will be administered Neople Latin week.

Gemcitabine and eighth day of the foreign / hospitalization are given over 30 minutes.

Regimen of the progression of the disease, the subject can not continue to deny or toxic dose every 3 weeks until at least 6 cycles should be administered to. Subjects completed six cycles of medication which responds subjects, the researchers believe it is necessary to sustain if the regimen is

Subjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week.

purpose Primary endpoint

* To evaluate the 24 month disease free survival Second endpoints
* To evaluate the 24 month overall survival To analyze the toxicity and the quality of life

Approximately 48 month from the date of IRB approval

Patients enrolled in this study targets approximately 314 people. Completion of patient enrollment is expected to take approximately 24 month, approximately 24 month follow-up period is expected to be needed

A Phase IIclinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

A Phase II Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Korean Gynecologic Oncology Group

Infections

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Virus Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Retinitis Pigmentosa 15

Antibodies

Antibodies, Monoclonal

Cisplatin

Immunomodulating Agents

Immunoglobulins

RP3 will be administered via direct intratumoral injection or via CT, ultrasound, or laryngoscopy guided intratumoral injection into superficial, subcutaneous (SC), or nodal lesions and into deeper lesions, including visceral lesions.

standard-of-care CCRT (defined as intensity-modulated radiation therapy \[IMRT\] and cisplatin

Genetically modified herpes simplex type 1 virus

CCRT consisting of intensity modulated radiation therapy combined with a cis-platinum

CCRT(concurrent chemoradiation therapy)

nivolumab

David Cohan, MD/FACS

This is a Phase 2, multicenter, open-label, 2-cohort (Locoregionally Advanced Cohort or Recurrent/Metastatic Cohort) study evaluating RP3 in combination with concurrent chemoradiation therapy (CCRT) followed by nivolumab (for the LA Cohort) or combined with chemotherapy and nivolumab (for the R/M Cohort) in patients with advanced, inoperable squamous cell carcinomas of the head and neck (SCCHN), including of the oral cavity, oropharynx, hypopharynx, larynx, or unknown primary.

RP3 is a genetically modified herpes simplex type 1 virus (HSV-1) that expresses exogenous genes (anti-CTLA-4 antibody, CD40 ligand and h4-1BBL) designed to directly kill tumor cells and generate a systemic anti-tumor immune response

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab With or Without Ipilimumab in Patients With Ovarian Cancer	NCT03245892	High Grade Sero... Fallopian Tube Primary Periton...	Carboplatin and... Nivolumab Cytoreductive s... Ipilimumab	18 Years -	Memorial Sloan Kettering Cancer Center
Adjuvant Sequential & Concurrent CarboTaxol + Radiotherapy for High Risk Endometrial Cancer	NCT03935256	Endometrial Can...	Carboplatin and... Radiation Thera...	18 Years -	Loyola University
Neoadjuvant Chemotherapy in Non Small Cell Lung Cancer (NSCLC) Stages IB, IIA, IIB, and IIIA/T3	NCT00273507	Non-small Cell ...	Carboplatin and...	18 Years - 75 Years	Rigshospitalet, Denmark
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer	NCT00050960	Non-small Cell ...	bexarotene with... carboplatin and...	-	Eisai Inc.
Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer	NCT01244789	Endometrial Can...	carboplatin and... observation	18 Years -	Danish Gynecological Cancer Group
Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer	NCT01244789	Endometrial Can...	carboplatin and... observation	18 Years -	Danish Gynecological Cancer Group
The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach	NCT04527900	Endometrial Can...	carboplatin and... pelvic IMPT (In...	18 Years -	University of Maryland, Baltimore
A Phase IIclinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer	NCT01570582	Fallopian Tube ... Ovarian Cancer Primary Periton...	carboplatin and...	18 Years - 70 Years	Korean Gynecologic Oncology Group
A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab With or Without Ipilimumab in Patients With Ovarian Cancer	NCT03245892	High Grade Sero... Fallopian Tube Primary Periton...	Carboplatin and... Nivolumab Cytoreductive s... Ipilimumab	18 Years -	Memorial Sloan Kettering Cancer Center
Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN	NCT05743270	Squamous Cell C... Locally Advance... Recurrent Head ...	RP3 CCRT(concurrent... carboplatin and... nivolumab	18 Years -	Replimune Inc.

Spots Global Cancer Trial Database for carboplatin and paclitaxel