Neoplasms

All Conditions

Symptoms and General Pathology

Blood and Lymph Conditions

Carcinoma

Recurrence

Thymoma

Thymus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Thoracic Neoplasms

Lymphatic Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Immunoglobulins

Ramucirumab

Lexatumumab

Antineoplastic Agents, Immunological

Immunoglobulins, Intravenous

Tubulin Modulators

Antimitotic Agents

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.

Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Anne S Tsao

This randomized phase II trial studies how well carboplatin and paclitaxel with or without ramucirumab work in treating patients with thymic cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ramucirumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known if giving carboplatin and paclitaxel with or without ramucirumab will work better in treating patients with thymic cancer.

PRIMARY OBJECTIVE:

I. To compare progression-free survival between patients with incurable unresectable locally advanced, or recurrent, or metastatic thymic carcinoma randomized to carboplatin-paclitaxel with or without ramucirumab.

SECONDARY OBJECTIVES:

I. To evaluate the frequency and severity of toxicity of carboplatin-paclitaxel with or without ramucirumab in this patient population.

II. To compare the response rate (complete response, partial response, confirmed and unconfirmed) between treatment arms.

III. To compare disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease) between treatment arms.

IV. To compare overall survival between treatment arms.

ADDITIONAL OBJECTIVE:

I. To bank specimens for future research.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive ramucirumab intravenously (IV) over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.

ARM B: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, and then every 6 months for 1 year.

Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery

A Randomized Phase II Trial of Carboplatin-Paclitaxel With or Without Ramucirumab in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma

Binary proportions will be compared between the arms using either a Fisher's exact or Chi-squared test at the 1-sided 0.10 level.

National Cancer Institute (NCI)

SWOG Cancer Research Network

Pembrolizumab

Lenvatinib

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Pembrolizumab 200 mg will be administered to patients as 30-minute IV infusion every 3 weeks (a window of -5 minutes and +10 minutes is permitted).

Lenvatinib 20 mg (2 capsules of 10 mg) will be administered daily at the same time, with or without food. At the day 1 of each cycle, lenvatinib will be administered within 4 hours after finishing pembrolizumab (lenvatinib after pembrolizumab). Lenvatinib cannot be chewed

Pembrolizumab 200 mg will be administered to patients as 30-minute intravenous infusion (a window of -5 minutes and +10 minutes is permitted) every 3 weeks.

Lenvatinib 20 mg (2 capsules of 10 mg) will be administered daily at the same time, with or without food. At the day 1 of each cycle, lenvatinib will be administered within 4 hours after finishing pembrolizumab (lenvatinib after pembrolizumab)

Lenvatinib 10 mg

Jordi Remon, MD, PhD

Benjamin Besse, MD, PhD

This is a multicentric, open-label, single arm phase II study to evaluate the efficacy and safety of the combination of pembrolizumab and lenvatinib in pre-treated thymic carcinoma patients who have progressed after at least one line of platinum-based chemotherapy for advanced disease without having received any previous immunotherapy (previous bevacizumab allowed, but not sunitinib), and not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD-L1 status.

Men and women aged ≥ 18 years old diagnosed with B3-thymoma or metastatic thymic carcinoma who have progressed after at least one line of platinum-based chemotherapy for advanced disease without having received any previous immunotherapy (previous bevacizumab allowed, but not sunitinib), and not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD- L1 status. Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria. Patients are not eligible if they are candidates for a local treatment with a curative intention. Patients must present Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 and with adequate organ function.

Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents

A Multicentric, Open-Label, Single Arm Phase II Study To Evaluate The Efficacy And Safety Of The Combination Of PEmbrolizumab And Lenvatinib In Pre-Treated Thymic Carcinoma PaTIents. PECATI.

PFS rate at 5 months, defined as the percentage of patients with B3-Thymoma and Thymic Carcinoma without disease progression at 5 months after starting the treatment combination.

Grade 3 and 4 AEs and serious adverse events (SAEs) will be assessed, according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v.5.0), to determine the safety and tolerability of the combination.

Merck Sharp & Dohme LLC

MedSIR

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Pleural Neoplasms

Respiratory Tract Neoplasms

Lung Diseases

Respiratory Tract Diseases

Pleural Diseases

Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit.

Palliative Therapy

Questionnaire Administration

Carolyn Presley, MD

This trial studies how well embedded palliative care works in managing symptoms in participants with stage III-IV thoracic malignancies that has come back and their caregivers. Embedded palliative care may improve distress and anxiety in participants and caregivers.

PRIMARY OBJECTIVES:

I. To determine feasibility of embedding a palliative care (PC) physician within the James Thoracic Oncology Clinic.

II. To assess patient and caregiver outcomes over a 12-month period within an embedded onco-palliative care clinic model.

III. To evaluate and describe clinician attitudes and beliefs regarding utilization of embedded palliative care as well as symptoms of provider burnout.

IV. To analyze health care utilization among participants receiving embedded onco-palliative care.

OUTLINE:

Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit.

After completion of study, patients are followed for up to 1 year.

Embedded Palliative Care in Managing Symptoms in Participants With Recurrent Stage III-IV Thoracic Malignancies and Their Caregivers

Embedded Palliative Care in the Management of Advanced Thoracic Malignancies

Acceptance will be evaluated utilizing provider surveys (to capture provider opinions on palliative care utilization) as well as rate of enrollment. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.

Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.

Clinician capacity and productivity will be evaluated by looking at scheduling as well as billing productivity. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.

Resources required, including patient care rooms and nursing support will also be evaluated. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.

Will be assessed using Supportive care screen.

Will be assessed using Functional Assessment of Cancer Therapy-Lung

Will be assessed using Hospital Anxiety and Depression Scale (HADS)

Will be assessed using National Comprehensive Cancer Network distress thermometer

Anxiety assessed using the Hospital Anxiety and Depression Scale

Depression assessed using the Hospital Anxiety and Depression Scale

Functional status assessment using Functional Activities Scale (FAS)

Caregiver needs assessment using Supportive Care Needs Survey - Patients \& Caregivers (SCNC-P\&C)

Ohio State Palliative Care Provider survey used to assess perceived barriers to referral

Will be captured using Integrated Health Information Systems electronic medical record data as well as patient reported events.

evaluate the challenges for patients, caregivers and treating oncologist in embedded palliative care

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery	NCT03694002	Locally Advance... Metastatic Thym... Recurrent Thymi... Unresectable Th...	Carboplatin Paclitaxel Ramucirumab	18 Years -	SWOG Cancer Research Network
Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents	NCT04710628	Metastatic Thym... Thymoma Type B3	Pembrolizumab Lenvatinib 10 m...	18 Years -	MedSIR
Embedded Palliative Care in Managing Symptoms in Participants With Recurrent Stage III-IV Thoracic Malignancies and Their Caregivers	NCT04662645	Caregiver Malignant Pleur... Metastatic Thym... Recurrent Lung ... Recurrent Thymi... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... Stage IIIC Lung... Stage IV Lung C... Stage IVA Lung ... Stage IVB Lung ...	Palliative Ther... Questionnaire A...	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for metastatic thymic carcinoma