Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Vemurafenib

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Enzyme Inhibitors

Arm A BRAF mutated patients. Over a period of 6 weeks (1) + (2):

1. Vemurafenib 960 mg bid p.o. from week 1 to week 6.
2. Cobimetinib 60 mg qd p.o. from week 1 to week 3 and week 5 to week 6. Week 4 off.

After surgery and a second screening period (up to six weeks): Atezolizumab 1200 mg IV for 52 weeks

Arm B BRAF mutated patients. Over a period of 6 weeks (1) + (2) + (3):

1. Vemurafenib 720 mg bid p.o. from week 1 to week 6.
2. Cobimetinib 60 mg qd p.o. from week 1 to week 3 and from week 5 to week 6. Week 4 off.
3. Atezolizumab 840 mg IV for 2 cycles (day 1 of week 4 and day 1 of week 7).

After surgery and a second screening period (up to six weeks): Atezolizumab 1200 mg IV for 52 weeks

Arm C BRAF WT patients. Over a period of six weeks (1) + (2):

1. Cobimetinib 60 mg qd p.o. from week 1 to week 3 and from week 5 to week 6,
2. Atezolizumab 840 mg IV for 2 cycles (day 1 of week 1 and day 1 of week 4).

After surgery and a second screening period (up to six weeks): Atezolizumab 1200 mg IV for 52 weeks

Cobimetinib 60 mg qd p.o. from week 1 to week 3 and week 5 to week 6. Week 4 off.

Cobimetinib 20 MG Oral Tablet

960 (arm A) /720 (arm B) mg bid p.o. from week 1 to week 6.

Vemurafenib 240 Mg Oral Capsule

840 mg IV for 2 cycles for Arm B and C. After surgery in all arms 1200 mg IV for 52 weeks

Atezolizumab 1200 MG in 20 ML Injection

Paolo Ascierto

Neoadjuvant plus adjuvant treatment with target therapy and immunotherapy given in combination or sequence may have an anti-tumour activity and may reduce the risk of relapse in patients with high-risk resectable melanoma (stage III B / C / D and oligometastatic stage IV).

Melanoma represents a considerable health burden and an ongoing area of unmet need in oncology. Despite melanoma accounts for only 1% of diagnosed skin cancers, it is the cause of most skin cancer-related deaths. Until recently, limited effective treatment options were available to patients with advanced melanoma. Historically, response rates to conventional chemotherapy and immunomodulation therapy (interleukin-2 or interferon-γ) have been reported at approximately 5-19%.

Adjuvant immune checkpoint blockade (ICB) and target therapy improve outcomes of patients with high-risk resectable melanoma. It has recently been demonstrated that treatment with neoadjuvant and adjuvant targeted therapy (dabrafenib and trametinib) is associated with a high pathologic complete response (pCR) rate and improved outcomes over surgery alone. However, treatment with ICB has not been well studied in the neoadjuvant setting, despite preclinical studies suggesting that neoadjuvant administration of ICB is associated with improved survival and enhanced anti-tumour immune responses compared to the same therapy administered in the adjuvant setting.

The advantage of neoadjuvant trials is the availability of blood and tumour tissue samples before and after systemic therapy for the conduct of novel mechanistic and biomarker studies in the circulation and the tumour microenvironment.

Prospective neoadjuvant clinical trials with targeted (dabrafenib/trametinib combo) or immunotherapeutic agents (nivolumab alone or nivolumab/ipilimumab combo) and combinations are now running in a subgroup of highrisk melanoma patients with pooled overall promising preliminary results of high rates of pathologic complete responses (pCRs, 30-50%) and early data of positive correlation between pCR and relapse-free survival. Based on the available results to date, we aim to conduct a randomized, noncomparative phase II trial to define the role of neoadjuvant plus adjuvant target and immunotherapy, given in combination or sequence, in patients with high risk surgically resectable melanoma.This approach has the potential to define whether neoadjuvant treatment has antitumour activity and whether it reduces the risk of relapse after surgery.

The study will be conducted according to an open-label, randomized, not comparative phase II design. Three arms for a total of 88 patients will be considered.

BRAF mutated patients will be randomized in two arms: Arm A and Arm B (27 patients per arm). BRAF WT patients will be included in Arm C (34 patients).

Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma

"NEOadjuvant Plus Adjuvant Therapy With Combination or Sequence of Vemurafenib, cobImetinib, and atezolizuMab in Patients With High-risk, Surgically Resectable BRAF Mutated and Wild-type Melanoma"

Defined as the lack of all signs of cancer in tissue samples removed during surgery

Defined as the time from randomisation to recurrence event or last follow-up

Defined as the time from the date of randomisation to the date of death due to any cause

Defined as the sum of pathologic complete responses (pCRs), near pathologic complete responses near pCRs) and pathologic partial responses (pPRs).

All AEs, Grade 3 to 4 AEs, serious adverse events (SAEs), deaths, AEs of special interest (AESIs), and AEs leading to treatment discontinuation or withdrawal from the study

Immunoscore, Circulating cytokines and chemokines profiling, Metabolomic profiling,Tumour mutational burden, Myeloid-derived suppressors cells, immune cell subtypes expression and lymphocyte activation, Additional analysis of protein levels (i.e. CCR5), DNA mutations, and/or mRNA analysis

Clinical Research Technology S.r.l.

Fondazione Melanoma Onlus

Respiratory Tract (Lung and Bronchial) Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Pharmaceutical Solutions

Immunomodulating Agents

Placebo will be supplied by the sponsor and will be identical in appearance to atezolizumab and will comprise the same excipients but without atezolizumab every 21 days

Atezolizumab will be supplied as sterile liquid in 20-mL glass vials. The vial is designed to deliver 20 mL (1200 mg) of atezolizumab solution but may contain more than the stated volume to enable delivery of the entire 20 mL volume. For information on the formulation and handling of atezolizumab, refer to the Atezolizumab Investigator's Brochure.

Atezolizumab 1200 mg in 20 ML Injection

Placebo will be supplied as sterile liquid in 20ml vials. the vial is designed

Placebo

Carmine Pinto, MD

Erika Gervasi, BS

ANGELO DELMONTE, MD

FEDERICA GROSSO, MD

ANNAMARIA CATINO, MD

HECTOR SOTO PARRA, MD

MICHELE DE TURSI, MD

ANTONIO FRASSOLDATI, MD

MANILO MENCOBONI, MD

ALBERTO PAVAN, MD

FAUSTO BARBIERI, MD

VINCENZO MOTESARCHIO, MD

VINCENZO MONTESARCHIO, MD

SILVIA NOVELLO, MD

GIULIA PASELLO, MD

MARCELLO TISEO, MD

PAOLO PEDRAZZOLI, MD

FEDERICO CAPUZZO, MD

ARMANDO SANTORO, MD

SALVATORE PISCONTI, MD

ALESSANDRA GUGLIELMI, MD

This is a multicentric double-blind, placebo controlled, phase III trial. In this study, patients who underwent to a surgical resection of pleural mesothelioma and are without signs of macroscopic residual disease will be randomized 2:1 to receive atezolizumab or placebo. Patients will be treated for 12 months or until recurrence, unacceptable toxicity or patient/physician decision, whichever occurs first.

Randomization will be done via a centralized system and patients will be stratified histology (epithelioid vs non epithelioid) and stage (I vs

\>I). Patients will be radiologically evaluated after surgical procedure before starting therapy and then every 12 weeks for 24 months or until disease progression. At screening patients should be without macroscopic residual disease. Quality of life questionnaire will be administered to patient at baseline and every 12 weeks. During the study baseline tumor blocks will be centrally analyzed to determinate biological characteristics and gene expression.

This is a multicentric double-blind, placebo controlled, phase III trial. In this study, patients who underwent to a surgical resection of pleural mesothelioma and are without signs of macroscopic residual disease will be randomized 2:1 to receive atezolizumab or placebo. Patients will be treated for 12 months or until recurrence, unacceptable toxicity or patient/physician decision, whichever occurs first. Randomization will be done via a centralized system and patients will be stratified histology (epithelioid vs non epithelioid) and stage (I vs

\>I).

This is a randomized, placebo-controlled, double-blind study. Patients will be randomized to one of the following treatment arms in a 2:1 ratio (experimental to control arm):

* Arm A (experimental arm): atezolizumab
* Arm B (control arm): placebo

Randomization will be stratified by the following factors:

* Histology (epithelioid vs non epithelioid)
* Stage (I vs \>I) Blinding Investigators and patients will remain blinded to treatment assignment until the final analysis of OS, except in the event unblinding is necessary for a medical emergency or to help guide decisions on subsequent treatment.

If the investigator wishes to know the identity of the study drug for any reason other than a medical emergency, he or she should contact the Scientific Responsible. In case of unblinding, patient will be withdrawn by the study.

Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso)

PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION

DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first.

Incidence, nature, frequency, duration, timing and severity of serious adverse events (SAEs) and non-serious adverse events (AEs) related to atezolizumab treatment graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5.

OS, defined as the time from start of study drug to the date of death from any cause

Gruppo Oncologico Italiano di Ricerca Clinica

Small Cell Lung Carcinoma

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Carboplatin

Vaccines

Etoposide

Etoposide phosphate

Immunologic Factors

- Induction (4 cycles, every 3 weeks): Carboplatin area under the curve (AUC) 5 (5 mg per milliliter per minute, administered intravenously on day 1 of each cycle) and etoposide (100 mg per square meter of body-surface area, administered intravenously on days 1 through 3 of each cycle) Atezolizumab, 1200 mg administered intravenously every 3 weeks on day 1 of each cycle)

- Maintenance (only patients without PD after 4 induction cycles, up to PD): Atezolizumab iv (1200 mg/IV on day 1 every 3 weeks) DCV intradermally (max. 6 doses) on weeks 1, 3, 6, 9, 21, 33.

- Induction (4 cycles, every 3 weeks): Atezolizumab, 1200 mg administered intravenously every 3 weeks on day 1 of each cycle)

- Maintenance (only patients without PD after 4 induction cycles, up to PD): Atezolizumab iv (1200 mg/IV on day 1 every 3 weeks)

- Maintenance (only patients without PD after 4 induction cycles, up to PD): DCV intradermally (max. 6 doses) on weeks 1, 3, 6, 9, 21, 33.

ADC Vaccine

- Induction (4 cycles, every 3 weeks): Carboplatin AUC 5 (5 mg per milliliter per minute, administered intravenously on day 1 of each cycle) and etoposide (100 mg per square meter of body-surface area, administered intravenously on days 1 through 3 of each cycle)

María González Cao

This is a single-arm Phase Ib/II multicenter open-label study, with translational sub-study, of atezolizumab plus autologous dendritic cell vaccine as maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC). It is expected that three Spanish sites will include patients in this study.

Patients will receive standard treatment with carboplatin and etoposide, plus atezolizumab for four 21-day cycles (induction phase), followed by a maintenance phase during which they will receive the dendritic cell vaccine (6 doses maximum) in combination with atezolizumab until they had unacceptable toxic effects, disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, or no additional clinical benefit.

The two primary endpoints are the investigator-assessed toxicity and the 6 months PFS, both in the intention-to-treat population. Secondary Outcome Measures include: Duration of clinical benefit (DCB), Overall survival (OS) and Overall response rate (ORR)

The translational substudy will include:

Analysis of tumor tissue samples will consist of PD-L1 Immunohistochemistry testing, RNA expression, Work Environmental Scale (WES) analysis, and flow cytometry in pretreatment fresh tumor tissue.

The analysis will consist of T cell immunophenotyping, DC immunophenotyping, Tumoral RNA analysis by nanostring and tumoral cell-free DNA analysis by WES and cytokine analysis

This is a single-arm Phase Ib/II multicenter open-label study, with translational sub-study, of atezolizumab plus autologous dendritic cell vaccine as maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC). It is expected that three Spanish sites will include patients in this study.

Patients will receive standard treatment with carboplatin and etoposide, plus atezolizumab for four 21-day cycles (induction phase), followed by a maintenance phase during which they will receive atezolizumab and dendritic cell vaccine combination until they had unacceptable toxic effects, disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, or no additional clinical benefit. The two primary endpoints are the investigator-assessed toxicity and the 6 months PFS, both in the intention-to-treat population.

In the Phase Ib safety lead-in portion, up to 6 patients will be enrolled into and evaluated for dose-limiting toxicities (DLT) during the first 2 cycles of the maintenance therapy. If \<2 out of 6 patients present with limiting toxicities, the administration of the investigational products will be deemed safe in the Phase 1b lead-in, therefore enrollment will be expanded into the Phase 2 cohort. Inclusion and treatment of up to 20 patients (including those enrolled in the Phase Ib lead-in) with atezolizumab and dendritic cell vaccination as maintenance therapy is finally expected.

Safety assessments will be based on adverse event reports, results of clinical laboratory tests, immune safety tests, physical examinations, vital sign measurements, Eastern Cooperative Oncology Group (ECOG) performance status both during the study, and up to six months following the last study drug administration. Adverse events (AEs) will be assessed throughout the study period and evaluated by using National Cancer Institute (NCI) Common Technology Criteria version of Adverse Events version 5.0 (NCI CTCAE v 5.0).

Tumor measurements will be performed by computed tomography (CT) scan at baseline, at week 6 (W6), at week 12 (W12), and every 9 weeks thereafter, to evaluate 6m PFS and response to treatment. The response will be evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and the immune-related response criteria (irRECIST) as a secondary endpoint. Brain magnetic resonance imaging (MRI) will be performed at baseline (mandatory as per clinical practice), and along with CT scan at each timepoint, if there are brain metastasis at baseline.

Patients with stable disease (SD), partial response (PR) or complete response (CR) after induction with chemotherapy plus atezolizumab (CT scan on W12) will continue during the maintenance phase with atezolizumab plus dendritic cell vaccine.

Treatment with atezolizumab will continue until disease progression (PD), significant clinical deterioration, unacceptable toxicity, or if any criteria for withdrawal from the trial is fulfilled.

Treatment with dendritic cell vaccines will continue for a maximum of 6 doses until PD, significant clinical deterioration, unacceptable toxicity, or if any criteria for withdrawal from the trial are fulfilled (whichever occurs first).

Treatment may continue after the initial determination of PD per RECIST 1.1 if the subject's performance status remains stable, and if the opinion of the principal investigator, the subject will benefit from continued treatment and if other criteria are fulfilled as outlined in the protocol.

For patients who have a confirmed CR or PR, it should be considered prophylactic cranial irradiation (PCI) after completion of chemotherapy (i.e., induction) based on the investigator's judgment. Following the completion of the induction part, PCI may be administered concurrently with atezolizumab and dendritic cell vaccination during the maintenance part. For those patients who have not progressed at the time of study drug discontinuation, the tumor assessments (including all disease locations) will be assessed radiologically by CT or MRI, as performed at screening, every 9 weeks (approximately 63 ± 7 days), until the occurrence of PD or study completion. The same method of assessment (CT or MRI) should be used to characterize tumors at screening and at all follow-up assessments. If positron emission tomography (PET) is used, it should also be accompanied by spiral CT or MRI.

Safety will be defined based on the rate of serious adverse events (SAEs) comparing with historic controls of atezolizumab in monotherapy as a maintenance treatment.

Kaplan Meier method will be used to estimate the survival function. Translational study

Tumor samples: All patients will undergo baseline tumor tissue acquisition prior to enrollment. The only mandatory tissue biopsy is pretreatment. Tissue samples:

Pre induction treatment fresh and paraffin-embedded tumor sample (If obtaining a fresh biopsy is not feasible, the case should be discussed with Coordinating Investigators) Pre maintenance phase (for those that rebiopsy is feasible) After 24 weeks on maintenance phase (for those patents that continue on treatment after w24 on maintenance and rebiopsy is feasible) At tumor progression (for those patients who progressed and rebiopsy is feasible).

Analysis of tumor tissue samples will consist of PD-L1 Immunohistochemistry testing, RNA expression, WES analysis, and flow cytometry in pretreatment fresh tumor tissue.

Peripheral blood samples: Peripheral blood samples will be collected:

Pre induction treatment Pre maintenance phase After 9 weeks of the first vaccination At progression of the disease The analysis will consist of T cell immunophenotyping, DC immunophenotyping, Tumoral RNA analysis by nanostring and tumoral cell-free DNA analysis by WES and cytokine analysis

single arm Phase Ib/II multicenter open label study, with translational sub-study

Combination of Atezolizumab With Dendritic Cell Vaccine in Patients With Lung Cancer

Phase Ib/II Trial of the Combination of Atezolizumab With Dendritic Cell Vaccination as Maintenance Treatment in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) After Induction Treatment

Calculated as the percentage of participants alive and without disease progression, as assessed by the Investigator using RECIST v1.1

he number of patients with AEs and SAEs, changes in laboratory values, vital signs, ECGs, and results of physician examinations graded according to the CTCAE v 5.0.

DCB calculated as the time (in months) from first dose of treatment to progression (or death from any cause) in patients who had a best overall response of CR, PR, or SD of ≥ 24 weeks.

Median Overall Survival (mOS) is calculated as the time from date of inclusion to date of death due to any cause.

Rate of patients that achieve partial or complete response as best response during study induction treatment

Rate of patients that have a further best response during maintenance treatment

Roche Pharma AG

Fundacion Clinic per a la Recerca Biomédica

Instituto Oncológico Dr Rosell

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Abemaciclib twice daily. 1 cycle of treatment is 21 days in length.

Atezolizumab on the first day of each 21-day cycle in combination with abemaciclib twice daily.

Group 1 - Atezolizumab: Patients with CDK12 loss will receive atezolizumab monotherapy on the first day of each 21-day cycle

Group 2 - Abemaciclib 150 mg + atezolizumab: Patients with CDK12 loss will receive atezolizumab on the first day of each 21-day cycle in combination with abemaciclib twice daily.

Abemaciclib 200 MG

Abemaciclib 150 MG

Ajjai Alva, MD

This research is studying two experimental drugs, abemaciclib and atezolizumab, alone and in combination with each other, to learn about the safety and effectiveness of these treatments and their side effects. This is an investigational study treatment for adult men with metastatic castrate resistant prostate cancer (mCRPC) who have progressive disease despite previous treatment with androgen deprivation therapy (ADT). One group of men (men without a genetic mutation called "CDK12 loss") will receive abemaciclib therapy alone. Two other groups of men (men with CDK12 loss in one group and men without CDK12 loss in the other) will receive the combination of abemaciclib and atezolizumab. Another group of men with CDK12 loss will receive atezolizumab therapy alone.

Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer

A Phase II Multi-Center Trial of Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer

Percentage of patients without disease progression at 6 months after start of treatment. Disease progression as defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria.

Dose safety for the combination of abemaciclib and atezolizumab is the DLT incidence in Arm B and the combination-therapy cohort of Arm C. DLT is defined in the protocol.

The percentage of patients with at least 50% decline in PSA from pretreatment baseline per PCWG3 criteria

CBR as estimated by proportion of evaluable patients who had complete response (CR), partial response (PR) or stable disease (SD) as their best response to treatment by PCWG3 criteria.

DOR among responders by PCWG3 criteria will be reported by treatment arm using Kaplan-Meier methods.

DOT among responders by PCWG3 criteria will be reported by treatment arm using Kaplan-Meier methods.

TTP among responders by PCWG3 criteria will be reported by treatment arm using Kaplan-Meier methods.

Assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0. Results will be submitted in tabular format, showing the number of each AESI by grade (names of AESI in rows; grades 1 - 5 in columns). AESIs are protocol-specific (as defined in the protocol).

Number of patients (in arms A and B) alive at 2 years after the end of their treatment.

Number of patients who responded to treatment (per PCWG3 criteria) alive at 2 years after the end of their treatment.

University of Michigan Rogel Cancer Center

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Cyclophosphamide

Albumin-Bound Paclitaxel

Epirubicin

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

2 weeks Atezolizumab monotherapy before biopsy, followed by a 12-week therapy with Paclitaxel + Carboplatin+ Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.

12-week therapy with Paclitaxel + Carboplatin + Atezolizumab every 3 weeks for 4 cycles. This will be followed by Epirubicin + Cyclophosphamide + Atezolizumab every 3 weeks for 4 cycles.

Atezolizumab 840 MG in 14 ML Injection

Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles

Paclitaxel 80 mg/m² IV weekly x 12 cycles

1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.

Biopsy Arm A

1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.

Biopsy Arm B

After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.

Surgery

Iris Reiser, Dr.

Hans-Christian Kolberg, Prof. Dr.

This is a randomized, open-label, adaptive, two arm, multicentre, Phase II trial comparing a neoadjuvant chemotherapy with PDL1-inhibition (Atezolizumab) and Atezolizumab two-week window to chemotherapy with PDL1-inhibition (Atezolizumab) and identify biomarkers predicting (early) response to or resistance against Atezolizumab (alone and with CTX) allowing patients stratification in future clinical trials

Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy

An Adaptive Randomized Neoadjuvant Two Arm Trial in Triple-negative Breast Cancer Comparing a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy (neoMono)

Pathological Complete Response defined as no residual invasive tumor cells in the breast and in the lymph nodes (ypT0/is, ypN0)

Safety (incidence, relationship, seriousness, and severity of all AEs, SAEs, AESIs coded by medical dictionary for regulatory activities (MedDRA), summarized by Preferred Term and System Organ Class and graded according to common terminology criteria of adverse events (CTCAE V5.0)

Pathological complete response defined as no residual invasive tumor cells in the breast and in the lymph nodes (ypT0/is, ypN0) in patients with an ER/PR expression of \<1% and an ER/PR expression of 1% to 10%.

Pathological complete response defined as no tumor cells (invasive and no non-invasive) in the breast but also in the lymph nodes (ypN0, ypT0)

Near pCR defined as residual tumor \<5 mm in the breast irrespective of in situ and lymph nodes status

Pathological Complete Response defined as no invasive tumor in the breast, irrespective of lymph node status

Decrease of Ki-67 expression versus baseline after 14/28 days (+/- 2 days) of treatment as continuous predictor

TILs after 14/28 days (+/- 2 days) of treatment as continuous predictor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma	NCT04722575	Melanoma	Cobimetinib 20 ... Vemurafenib 240... Atezolizumab 12...	18 Years -	Fondazione Melanoma Onlus
Atezolizumab Versus Placebo for the Adjuvant Treatment of Malignant Pleural Mesothelioma (Atezomeso)	NCT04996017	Mesotheliomas P...	Atezolizumab 12... Placebo	18 Years -	Gruppo Oncologico Italiano di Ricerca Clinica
Combination of Atezolizumab With Dendritic Cell Vaccine in Patients With Lung Cancer	NCT04487756	Extensive-stage...	Atezolizumab 12... ADC Vaccine Carboplatin	18 Years -	Instituto Oncológico Dr Rosell
Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma	NCT04722575	Melanoma	Cobimetinib 20 ... Vemurafenib 240... Atezolizumab 12...	18 Years -	Fondazione Melanoma Onlus
Abemaciclib With or Without Atezolizumab in Metastatic Castration Resistant Prostate Cancer	NCT04272645	Prostate Cancer	Abemaciclib 200... Atezolizumab 12... Abemaciclib 150...	18 Years -	University of Michigan Rogel Cancer Center
Study to Compare a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy	NCT04770272	Triple-negative...	Atezolizumab 84... Atezolizumab 12... Carboplatin Paclitaxel Epirubicin Cyclophosphamid... Biopsy Arm A Biopsy Arm B Surgery	18 Years -	Palleos Healthcare GmbH
Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors	NCT04975958	Locally Advance...	AN2025 AN0025 Atezolizumab 12...	18 Years -	Adlai Nortye Biopharma Co., Ltd.

Spots Global Cancer Trial Database for atezolizumab 1200 mg in 20 ml injection