Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Death

Carcinoma

Disease Progression

Thymoma

Thymus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Avelumab

Antineoplastic Agents, Immunological

Avelumab will be administered at a dose of 10 mg/kg intravenously once every two weeks until disease progression or development of intolerable adverse events.

Shannon G Swift, R.N.

Arun Rajan, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

Thymoma and thymic carcinoma are cancers originating in the thymus gland. Platinum-based chemotherapy is standard treatment for them. But not uncommonly, the disease returns and people need more treatment to keep the cancer from growing. The drug Avelumab could help the immune system fight cancer.

Objective:

To test if avelumab is safe and well-tolerated, and is effective in treating relapsed or refractory thymoma and thymic carcinoma.

Eligibility:

People ages 18 and older with thymoma or thymic carcinoma that has returned or progressed after platinum-containing chemotherapy

Design:

Participants will be screened with:

* Blood, urine, and heart tests
* Scan: They lie in a machine that takes pictures of the body.
* Physical exam
* Medical history
* Biopsy: a needle removes a piece of tumor. Samples can be from a previous procedure, although it is desirable to undergo a new biopsy.

Participants will have treatment in 2-week cycles. They will continue until the side effects are not tolerable or their disease gets worse. Visits at the following time points are required per protocol. Patients who respond to treatment or have durable stability after at least 12 months of therapy may undergo a dose de-escalation regimen to continue on therapy.

* Every 2 weeks: Participants will get avelumab by infusion in a vein (IV). They will get diphenhydramine (benadryl) and acetaminophen (tylenol) by mouth or IV before receiving avelumab to decrease the chances of developing a reaction to avelumab. They will have blood, urine, and heart tests periodically.
* Cycles 4 and 7, then every 6 weeks: Scans will be performed to look for shrinkage or growth of tumor.
* Cycle 4: Participants will be offered a chance to undergo a biopsy.
* 2-4 weeks after stopping treatment: Blood, urine, and heart tests will be performed. Participants might undergo a scan.
* 10 weeks after stopping treatment: Blood, urine, and heart tests.
* About 6 months after stopping treatment, then every 3 months: Participants will have scans andcan allow genetic testing on their blood and tissue samples.

Background

Platinum-based chemotherapy is the standard of care for advanced unresectable thymic epithelial tumors (TETs). However more than half of these patients experience disease recurrence and require second-line therapy. There are no approved drugs for treatment of recurrent thymoma and thymic carcinoma and new therapeutic options are needed for patients who have disease progression on or after platinum-containing therapy. The clinical activity of checkpoint blockade targeting programmed death 1 (PD-1) and its ligand (PD-L1) has been demonstrated against various tumor types. We have demonstrated the ability of avelumab to induce major responses in patients with advanced thymoma in a phase I dose escalation study. Further investigation of avelumab in patients with TETs is needed to define the clinical activity and safety of immune checkpoint blockade in patients with TETs.

Primary Objectives

To determine the safety and tolerability of avelumab in participants with relapsed or refractory thymoma and thymic carcinoma.

To determine the objective response rate (ORR) to avelumab in participants with relapsed or refractory thymoma and thymic carcinoma.

Eligibility

Participants with histologically confirmed, unresectable thymoma or thymic carcinoma who have previously been treated with at least one platinum-containing chemotherapy regimen with progressive disease prior to study entry

Prior treatment with immune checkpoint inhibitors is permitted if the reason for discontinuation was not disease progression or life-threatening adverse events (laboratory abnormalities alone with prior therapy will not exclude participants from this trial)

Measurable disease by RECIST 1.1 criteria

Adequate renal, hepatic and hematopoietic function

No major surgery, radiotherapy, chemotherapy or biologic therapy within 28 days of avelumab

No prior thymic tumor-associated autoimmune disease with the exception of pure red cell aplasia and vitiligo.

Design

This will be a single-arm, pilot study to determine the clinical activity and safety of treatment with avelumab in participants with relapsed or refractory thymoma and thymic carcinoma.

Avelumab will be administered at a dose of 10 mg/kg intravenously once every two weeks until disease progression or development of intolerable adverse events. The two week period will constitute one cycle.

Per the study team s discretion, participants who respond to treatment or have durable stability after at least 12 months of therapy may undergo a dose de-escalation regimen to continue on therapy.

Toxicity will be assessed every cycle by CTCAE version 5.0.

Tumor response will be assessed after completion of every third cycle (6 weeks) using RECIST criteria, version 1.1.

When possible, a tumor biopsy will be conducted pre-treatment and on C4D43 to evaluate treatment-related, intra-tumoral changes.

A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy

.All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Objective response rate; i.e., the number of participants with complete response + the number with partial response confirmed via RECIST 1.1

National Cancer Institute (NCI)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Transitional Cell Carcinoma

Atezolizumab

Mitogens

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immune Checkpoint Inhibitors

Immunologic Factors

Patients with urothelial cancer were treated with derazantinib 300 mg once daily

Patients with any solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as intravenous (IV) infusion

Patients with any solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Patients with FGFR inhibitor resistant urothelial cancer were treated with derazantinib 300 mg once daily

Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Patients with urothelial cancer were treated with derazantinib 200 mg twice daily

Derazantinib was administered orally at a dose of 300 mg once daily

Derazantinib 300 mg once daily monotherapy

Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Derazantinib 200 mg once daily + atezolizumab 1200 mg

Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Derazantinib 300 mg once daily+ atezolizumab 1200 mg

Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks

Derazantinib 200 mg twice daily + atezolizumab 1200 mg

Derazantinib 300 mg once daily monotherapy (QD)

Derazantinib 300 mg once daily + atezolizumab 1200 mg

Derazantinib was administered orally at a dose of 200 mg twice daily

Derazantinib 200 mg twice daily monotherapy

Manuel Häckl, MD

The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.

The study comprised five open-label substudies (1-5) in patients with advanced urothelial cancer harboring FGFR GA (with the exception of substudy 2 which did not require a FGFR GA) who were treated by derazantinib monotherapy or derazantinib in combination with atezolizumab. The study enrolled patients with cisplatin-ineligible status, or patients whose disease progressed after either first-line treatment or prior treatment with FGFR inhibitors.

Derazantinib and Atezolizumab in Patients With Urothelial Cancer

An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations

ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1

The RP2D was determined by a joint decision taken by the Independent Data Monitoring Committee (IDMC), Investigators, and the Sponsor in reviewing the aggregate of DLT and AE data, and considering efficacy data

In Substudy 2, the primary endpoint was the number of patients with DLTs. A DLT was defined as a clinically-significant adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications. Any DLT had to be a toxicity considered at least possibly related to derazantinib or the combination of derazantinib and atezolizumab

DCR was defined as the proportion of patients who achieved a confirmed clinical response (CR), partial response (PR) or stable disease (SD) by BICR using the internationally recognized criteria in accordance with RECIST Version 1.1

DOR was calculated from the first date of documented tumor response (confirmed CR or PR) to the date of disease progression as assessed by BICR or death per RECIST 1.1

PFS was calculated as the time from cohort assignment until disease progression as assessed by BICR, or death from any cause, whichever came first

OS was calculated from the date of cohort assignment until death from any cause

Common Terminology Criteria for Adverse Events (CTCAE) displayed by increasing severity grades 3 to 5 (CTCAE grade 3/4/5 )

Basilea Pharmaceutica

Patients with urothelial cancer were treated with derazantinib 300 mg once daily

Derazantinib 300 mg once daily monotherapy: Derazantinib was administered orally at a dose of 300 mg once daily

Substudy 1: Derazantinib 300 mg Once Daily

Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Derazantinib 200 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily + Atezolizumab 1200 mg

Patients with solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg

Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Derazantinib 200 mg twice daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks

Substudy 3: Derazantinib 200 mg Twice Daily + Atezolizumab 1200 mg

Substudy 4 (Cohort 4a):Derazantinib 300 mg Once Daily

Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Substudy 4 (Cohort 4b):Derazantinib 300 mg Once Daily + Atezolizumab 1200 mg

Patients with urothelial cancer were treated with derazantinib 200 mg twice daily

Derazantinib 200 mg twice daily monotherapy: Derazantinib was administered orally at a dose of 200 mg twice daily

Substudy 5: Derazantinib 200 mg Twice Daily

Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Derazantinib 200 mg once daily+ atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Substudy 2 (Dose-Level 1): Derazantinib 200 mg Once Daily+ Atezolizumab 1200 mg

Patients with solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Derazantinib 300 mg once daily+ atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Substudy 2 (Dose-Level 2): Derazantinib 300 mg Once Daily+ Atezolizumab 1200 mg

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Bladder

Renal pelvis

Ureter

Missing

Other site of primary tumor

Site of primary tumor at diagnosis

Scale 0

Scale 1

Scale 2

The ECOG PS scale indicates increasing levels of disability, with 0 indicating fully active; 1, restricted in strenuous activity; 2, restricted in work activity but ambulatory and capable of self-care

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

One treatment

Two treatments

Three or more treatments

No treatment

Number of previous anti-cancer treatments

Prior immune checkpoint inhibitor treatment

Treatment completed

Progressive disease

Toxicity

Other

Unknown

No previous therapy

Reason previous therapy ended

Study Director

Efficacy analyses were performed using the modified Intent-to-Treat (mITT) population: all patients who received at least one dose of derazantinib or atezolizumab, and had at least one post-baseline imaging assessment in accordance with RECIST 1.1, or documented clinical progression

Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5)

Patients with solid tumors were treated with derazantinib 200 mg or 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Substudy 2 Combined (Dose-Level 1 and 2): Derazantinib 200 or 300 Once Daily+ Atezolizumab 1200 mg

The safety/intent-to-treat (ITT) population consisted of all patients who received at least one dose of derazantinib or atezolizumab

Recommended Phase 2 Dose (RP2D) of Derazantinib-atezolizumab in Combination Based on DLT Criteria, Safety and Efficacy Data (Substudy 2)

The maximum tolerated dose (MTD)-determining population included all patients enrolled in the MTD Part of each dose level who met the following minimum criteria during the DLT period:

* received at least one dose of derazantinib and atezolizumab and has experienced a DLT;
* received ≥ 90% of the derazantinib and atezolizumab dose, respectively, in Cycle 1 and did not experience a DLT, have been observed for ≥ 21 days following the first dose, and have been evaluated for safety

Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2

Disease Control Rate (DCR) Per RECIST 1.1 in All Substudies

Duration of Response (DOR) Per RECIST 1.1

Efficacy analyses were performed using the modified Intent-to-Treat (mITT) population: all patients who received at least one dose of derazantinib or atezolizumab, and had at least one post-baseline imaging assessment in accordance with RECIST 1.1, or documented clinical progression.

ORR Based on RECIST 1.1 (Substudy 2)

Progression-free Survival (PFS) by RECIST in All Substudies

Overall Survival (OS) in All Substudies

Number of Patients With at Least Grade 3 Adverse Events (AEs)

Patients with solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as intravenous (IV) infusion

Derazantinib 200 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion

Derazantinib 300 mg once daily + atezolizumab 1200 mg: Derazantinib was administered orally at a dose o f 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks

Overall Study

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Anti-Infective Agents

Bevacizumab

Doxorubicin

Liposomal doxorubicin

Immunomodulating Agents

Durvalumab

Chlorotrianisene

Tremelimumab

Angiogenesis Inhibitors

Growth Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Durvalumab, bevacizumab, tremelimumab and TACE

1,150 mg flat dose every 21 days, starting on day 1 of cycle 1

durvalumab

used for TACE (only in patients with HCC BCLC stage B)

Doxorubicin-Eluting Beads

TACE with Doxorubicin-Eluting Beads (only in patients with HCC BCLC stage B) on Cycle 2. More TACE can be done if clinically necessary.

TACE

7.5 mg/kg dose every 21 days, starting on day 1 of cycle 2

bevacizumab

300, 150 or 75 mg once on day 1 of cycle 1

Donna M Hrones, C.R.N.P.

Tim F Greten, M.D.

Background:

Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Most people with advanced HCC survive an average of 6 to 9 months. Researchers are evaluating a combination of treatment drugs to delay the progression of HCC; aiming to help people with HCC live longer.

Objective:

To study the 6-month progression-free survival in people with advanced HCC treated with bevacizumab, durvalumab, and TACE.

Eligibility:

Adults ages 18 and older with intermediate or advanced HCC

Design:

Participants will be screened with a physical exam and medical history. They will have tests to evaluate their hearts as well as blood and urine. A CT and/or MRI scans will be done during the study. If a prior tumor sample is not available; participants may undergo a biopsy. They may undergo an endoscopy of their esophagus and stomach.

Participants will get the study drugs in 21-day cycles:

Two treatment drugs will be injected into a vein every 3 weeks.

Patients will have an interventional treatment procedure done by interventional radiology under sedation; chemotherapy beads will be infused into artery branches in the liver. Participants may have to stay in the hospital for 24 hours for observation, after this procedure. This interventional procedure may be done more than once during the study.

Participants may need to repeat some of the screening tests throughout the study.

Participants may have to stop taking some of their cancer treatment drugs during the study.

Participants will continue on the study until their cancer progresses or until the side effects of the treatment drugs are not tolerable.

Background:

Worldwide, hepatocellular carcinoma (HCC) is the fourth most common cause of cancer related death with a median survival of 6-9 months.

Biliary tract carcinoma (BTC) is relatively uncommon and includes cancers of the gallbladder and intra- and extra-hepatic biliary ductal system, although periampullary tumors are often considered part of this group as well.

A class of agents that in the recent years has been at the epicenter of immunotherapy approaches in gastrointestinal malignancies are the monoclonal antibodies (mAbs) against the immune checkpoint inhibitors CTLA4, PD-1 and PD-L1.

Durvalumab is a human monoclonal antibody of the immunoglobulin G1 kappa (IgG1k ) subclass. Durvalumab inhibits binding of programmed cell death ligand 1 (PD-L1) to programmed cell death 1 (PD-1) and CD80. Anti-PD-L1 antibodies directly target tumor cells and are expected to have less adverse events in comparison with anti-PD-1 antibodies that target effector T-cells in the tumor microenvironment.

Tremelimumab is a human IgG2 mAb directed against CTLA-4. Tremelimumab blocks the inhibitory effect of CTLA-4, and therefore enhances T cell activation.

Angiogenesis is defined as the formation of new blood capillaries, which is a complex process that promotes vascular endothelial growth factor (VEGF) and other proangiogenic factor expression, thus enhancing metastasis. Inhibition of VEGF function by bevacizumab can lead to the inhibition of the new blood vessels formation surrounding a tumor, and consequently arrest the tumor growth by depriving essential nutrients and oxygen.

TACE has been shown to induce anti-tumor immunity.

Early phase studies have shown that anti-VEGF treatment with bevacizumab in combination with TACE decreases neovascular formation.

We have previously shown that locoregional therapies can be safely combined with immune checkpoint blockade. There are also preclinical data suggesting that anti-VEGF therapy may target myeloid cells with suppressor activity.

Objectives:

To evaluate the 6-month progression free survival (PFS) in patients with advanced HCC BCLC stage B treated with bevacizumab, durvalumab, tremelimumab and TACE.

To evaluate the 6-month PFS in patients with BTC and HCC BCLC stage C treated with bevacizumab, durvalumab and tremelimumab.

Eligibility:

Histopathological confirmation of HCC or BTC or histopathological confirmation of carcinoma in the setting of clinical and radiological characteristics which, together with the pathology, are highly suggestive of a diagnosis of BTC.

Patients must have evaluable or measurable disease per RECIST 1.1.

Patients must have disease that is not amenable to potentially curative resection, radiofrequency ablation, or liver transplantation.

Design:

This is an open label Phase II trial conducted to evaluate efficacy of durvalumab, bevacizumab and tremelimumab combined treatment in patients with advanced HCC BCLC stage C or BTC and efficacy of durvalumab, bevacizumab, tremelimumab and TACE combined treatment in patients with advanced HCC BCLC stage B.

Initially 3-18 patients with HCC BCLC Stage C or BTC will be enrolled into safety run-in of Arm 1 to determine the safety of combined treatment of durvalumab, bevacizumab and tremelimumab.

Once safety has been determined, subsequent patients with HCC BCLC Stage C and BTC will be enrolled in Arm 1 and patients with HCC BCLC Stage B will start enrollment into Arm 2, consistent of durvalumab, bevacizumab, tremelimumab and multiple TACE procedures.

Treatment will continue until progression or unbearable toxicity.

Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma

A Phase II Study of Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinoma (BTC)

.All IPD recorded in the medical record will be shared with intramural investigators upon request.@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP

Proportion of patients with advanced HCC BCLC stage B that have progressive disease after 6 months

Proportion of patients with BTC and HCC BCLC stage C that have progressive disease after 6 months

Proportion of patients whose tumors shrunk after therapy

Median amount of time subject survives after therapy

List of adverse event type, grade and frequency

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pembrolizumab

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Completion of four cycles of Sequential Consolidation of Pembrolizumab 200mg every 21 days and then four cycles Nab-paclitaxel 100 mg/mg2 on day 1 and day 8 every 21 days

Completion of 4 cycles of Sequential Consolidation of Nab-paclitexel 100 mg/m2 on day 1 and day 8 every 21 days and then Pembrolizumab 200 mg every 21

Concurrent Consolidation of Nab paclitaxel 100 mg/m2 on day 1 and day 8 plus Pembrolizumab 200 m5 on day 1 every 21 days for four cycles

Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.

Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.

Jared Weiss, MD

The purpose of this research study is to test the effectiveness of three treatment arms that are designed to improve survival in patients with non-small cell lung cancer. Eligible subjects could be randomized to four (4) cycles of chemotherapy followed by immunotherapy, or immunotherapy followed by chemotherapy, or four cycles of chemotherapy plus immunotherapy.

This open-label, three-arm, non-comparative randomized phase II study is designed to evaluate three different sequences of double-consolidation with the humanized monoclonal antibody targeted against cell surface receptor programmed cell death-1 (PD-1), pembrolizumab, and nab-paclitaxel in patients with advanced Non small cell lung cancer post induction chemotherapy. While the goal of each arm is to guarantee exposure to each of these two agents to patients who have not progressed post induction chemotherapy, they do so with different sequence. In ARMs A and B, consolidation is sequential, with either pembrolizumab followed by nab-paclitaxel (ARM A), or nab-paclitaxel followed by pembrolizumab (ARM B). In ARM C, consolidation is concurrent, with the two agents administered concurrently. As of July 24, ARMs B and C are closed, and no patients will be enrolled on this study. ARM A remains open to enrollment.

Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel

Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel After Standard First-Line Induction Chemotherapy in Advanced NSCLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy	NCT03076554	Thymoma Thymic Carcinom...	Avelumab	18 Years -	National Institutes of Health Clinical Center (CC)
Derazantinib and Atezolizumab in Patients With Urothelial Cancer	NCT04045613	Urothelial Carc...	Derazantinib 30... Derazantinib 20... Derazantinib 30... Derazantinib 20... Derazantinib 30... Derazantinib 30... Derazantinib 20...	18 Years -	Basilea Pharmaceutica
Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma	NCT03937830	Hepatocellular ... Hepatocellular ... Metastatic Hepa...	durvalumab Doxorubicin-Elu... TACE bevacizumab Tremelimumab	18 Years -	National Institutes of Health Clinical Center (CC)
Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel	NCT02684461	Non Small Cell ...	Pembrolizumab	18 Years - 99 Years	UNC Lineberger Comprehensive Cancer Center
BreastVAX: Radiation Boost to Enhance Immune Checkpoint Blockade Therapy	NCT04454528	Breast Cancer	Hypofractionate... Pembrolizumab i... Blood and tissu...	18 Years -	Abramson Cancer Center at Penn Medicine
Derazantinib and Atezolizumab in Patients With Urothelial Cancer	NCT04045613	Urothelial Carc...	Derazantinib 30... Derazantinib 20... Derazantinib 30... Derazantinib 20... Derazantinib 30... Derazantinib 30... Derazantinib 20...	18 Years -	Basilea Pharmaceutica

Spots Global Cancer Trial Database for immune checkpoint blockade