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Dissection, Blood Vessel

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All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

IBI308 200mg intravenous drip every three weeks following adaptive radiation therapy.

A humanized anti-PD-1 monoclonal antibody

IBI308

Haihua Yang, MD

Yinnan Meng, MD

Fengming (Spring) Kong, MD

This phase II study is to evaluate the safety and efficacy of CT-based adaptive radiation therapy followed by adjuvant anti-PD-1 antibody immunotherapy in treating patients with different types and stages of thoracic malignancies. (CARTAI)

PRIMARY OBJECTIVES:

I. To evaluate the safety and toxicity of anti-programmed cell death 1 (PD-1) inhibition consolidation therapy after radiation therapy for multiple thoracic malignancies.

SECONDARY OBJECTIVES:

I. To assess the efficacy of adjuvant anti-PD-1 antibody immunotherapy after radiotherapy.

II. To understand the dynamics and interactions of IDO with others immune pathway biomarkers.

III. To evaluate whether IDO immune status could predict the treatment outcomes of radiation and immune combined therapy.

CT-Guided Adaptive Radiation Therapy Combine With Anti-PD-1 Antibody Adjuvant Immunotherapy for Thoracic Cancer Patients

A Safety and Efficacy Study of CT-Guided Adaptive Radiation Therapy With Anti-PD-1 Antibody Adjuvant Immunotherapy in Patients With Thoracic Cancer (CARTAI)

Number of participants with adverse events and serious adverse events at 6 months will be measured. \[CTCAE v4.03\]

Objective response rate is the percentage of patients with at least once occurrence of PR or CR \[RECIST v1.1\]

Duration of response is the time interval from first occurrence of PR or CR until PD or death \[RECIST v1.1\]

Number of patients with acute and chronic adverse events will be measured \[CTCAE v4.03\]

Progression-Free-Survival is the time interval from the start of treatment until disease progression or death by any cause \[RECIST v1.1\]

Overall Survival is the time interval from the start of treatment to death from any cause.

Taizhou Hospital

Head of Department of Radiation Oncology, Chief Physician

Neoplasms

Skin and Connective Tissue 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

Acral Lentiginous Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Antineoplastic Agents

Interferons

Antiviral Agents

Participants will be treated with IBI310 in combination with IBI308

Participants will be treated with recombinant interferon a-2B

In this group, subjects will be given IBI310 3mg/kg IV Q3W in combination with IBI308 200mg IV Q3W for 4 cycles, then follow up a maintenance therapy performed with IBI310 3mg/kg IV Q12W in combination with IBI308 200mg IV Q3W until disease progression or loss of clinical benefit.

IBI310+IBI308

In this group, subjects will be given IBI308 200mg IV Q3W until disease progression or loss of clinical benefit

In this group, subjects will be given 15\*10\^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5 weekly for 4 weeks.Then 9\*10\^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks

High-dose recombinant interferon a-2B

This is a phase III randomized, control, multi-center study of recombinant humanized anti-PD-1 mAb in combination with CTLA4 mAb for injection compared to high-Dose interferon in patients with acral melanoma that has been removed by surgery.

The Study of IBI310 in Combination With IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery

A Phase 3, Open-label, Multicenter Study, IBI310 in Combination With IBI308 and IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery

to evaluate the Recurrence free survival (RFS) of the patients with acral melanoma treated by IBI310 in Combination With IBI308 and high-Dose interferon

to evaluate the Overall survival (OS) of the patients with acral melanoma treated by IBI310 in Combination With IBI308 and high-Dose interferon

Innovent Biologics (Suzhou) Co. Ltd.

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Docetaxel

Tubulin Modulators

Antimitotic Agents

injection; dosage form: 10ml:100mg; frequency: 200mgQ3W; duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria

injection; dosage form: 1ml:40mg; Frequency: 75mg/m2 Q3W; duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria

Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial.

As 2nd line treatment to subjects with squamous NSCLC

Yuankai Shi, Doctor

Clinical trial results demonstrate that anti-PD-1 antibodies prolonged OS to approximately 9 months compared with 6 months in docetaxel group. Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial.

Additionally, the correlation between PD-L1 expression and the response to IBI308 treatment in Chinese squamous cell NSCLC patients as well as the role of irRECIST in immune checkpoint inhibitor treatment evaluation will also be assessed

A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC

Efficacy and Safety Evaluation of IBI308 Versus Docetaxel in Patients With Advanced or Metastatic Squamous Cell Lung Cancer After Failure of First-line Platinum-based Therapy- a Randomized, Open-label, Multicenter, Parallel, Phase 3 Study (ORIENT-3)

Overall survival was defined as the time from randomization to death due to any cause.

Progression-free survival (PFS) was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumours (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, or unequivocal progression of non-target lesion. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by investigators per RECIST 1.1 was reported for each arm.

ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented.

For participants who demonstrated a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions or unequivoval progression of non-target lesion. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who experienced a CR or PR is presented.

TEAE is any AE that developed or worsened in severity compared to the baseline during the period from first dose of any study treatment up to 90 days after the last dose of any study treatment. Percentage of participants experiencing TEAE is calculated.

All adverse events, including serious adverse events, will be collected since the consent form is signed until 90th day after last administration of investigation products, either observed by investigator or by the spontaneous reported by subjects.

Sintilimab 200mg Intravenously every 3 weeks

Sintilimab

Docetaxel 75mg/m2 Intravenously every 3 weeks

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

China

Region of Enrollment

Yi Bo

All randomized participants excluding participants in the docetaxel arm who initiated immunotherapy before receiving docetaxel or disease progression.

Overall Survival

Progression-free Survival by Investigators' Assessment

Overall Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigators

Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigators

All participants who received ≥1 dose of study treatment

Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

Overall Study

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Sintilimab consolidation therapy after concurrent chemoradiation, 200mg IV, every 3 weeks, until progressive disease (PD, unless patients can continuously benefit from study treatment per investigators' judgement), start new anti-cancer therapy, intolerable toxicity, withdraw informed consent or other conditions that require study treatment discontinuation. Sintilimab will be given at a maximum of 12 months.

Consolidation Sintilimab

Jinming Yu, Ph.D

This is an open label, multi-center, randomized, control phase III trial, to compare the efficacy and safety of consolidation therapy with sintilimab (IBI308) versus best supported care (BSC), in unresectable stage III NSCLC patients who do not experience disease progression after initial concurrent chemoradiation.

This is an open label, multi-center, randomized, control study of sintilimab versus BSC in unresectable local advanced stage III NSCLC patients without disease progression after concurrent chemoradiation.

Consolidation Sintilimab After Concurrent Chemoradiation in Patients With Unresectable Stage III NSCLC

CONSIST: A Phase III Randomized Control Study of Consolidation Sintilimab (IBI308) After Concurrent Chemoradiation Versus Chemoradiation Alone in Patients With Unresectable Local Advanced Stage III NSCLC

PFS (per RECIST 1.1 as assessed by the investigator) will be defined as the time from the date of randomisation until the date of objective disease progression or death (by any cause in the absence of progression).

OS (per RECIST 1.1 as assessed by the investigator) is defined as the time from the date of randomisation until death due to any cause.

ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).

DCR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR), or stable disease (SD).

DoR (per RECIST 1.1 as assessed by the investigator) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) until the date for the first documented response of progressive disease (PD) or death in the absence of progression.

PFS rate at 12/18 months is defined as the proportion (%) of patients who are alive and progression free at 12 and 18months from the date of randomisation.

The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v4.03 from the date of randomization to 90 days after last dose of study treatment.

Shandong Cancer Hospital and Institute

President of Shandong Cancer Hospital and Institute

Micronutrients

Hematinics

Vitamins

Bevacizumab

Carboplatin

Pemetrexed

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Neoadjuvant therapy followed by surgery. Neoadjuvant therapy included four drugs. IBI308 was given 200 mg iv infusion on day 1 of each 21-day cycle for 4 cycles; bevacizumab was administered at a dose of 15 mg/kg; pemetrexed was given 500 mg/m\^2 i.v. injection on day 1 of each 21-day cycle for 4 cycles; carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 4 cycles. Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.

IBI308 was given 200 mg iv infusion on day 1 of each 21-day cycle for 4 cycles.

Bevacizumab was administered at a dose of 15 mg/kg on day 1 of each 21-day cycle for 4 cycles.

Pemetrexed was given 500 mg/m\^2 i.v. injection on day 1 of each 21-day cycle for 4 cycles.

Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 4 cycles.

Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.

Thoracic surgery

Si-Yu Wang, MD

Si-Yu Wang, Doctor

The purpose of this study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer.

Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. IBI308 (sintilimab) is a recombinant humanized anti-PD-1 monoclonal antibody. This study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer.

Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Unresectable Stage III NSCLC

A Multicenter Phase II Trial of Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Patients With Unresectable Stage III Non-Small Cell Lung Cancer

Event-free survival was defined as the time from registration to disease progression (local relapse or distant metastases) or death from any cause, whichever came first.

Overall survival was assessed from randomization to death as a result of any cause.

Resectability rate was defined as the percentage of patients who were able to undergo surgery after induction.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CT-Guided Adaptive Radiation Therapy Combine With Anti-PD-1 Antibody Adjuvant Immunotherapy for Thoracic Cancer Patients	NCT03732430	Thoracic Malign...	IBI308	18 Years - 75 Years	Taizhou Hospital
The Study of IBI310 in Combination With IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery	NCT04277663	Acral Melanoma ...	IBI310+IBI308 IBI308 High-dose recom...	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
CT-Guided Adaptive Radiation Therapy Combine With Anti-PD-1 Antibody Adjuvant Immunotherapy for Thoracic Cancer Patients	NCT03732430	Thoracic Malign...	IBI308	18 Years - 75 Years	Taizhou Hospital
The Study of IBI310 in Combination With IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery	NCT04277663	Acral Melanoma ...	IBI310+IBI308 IBI308 High-dose recom...	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC	NCT03150875	Non-small Cell ...	IBI308 Docetaxel	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
Consolidation Sintilimab After Concurrent Chemoradiation in Patients With Unresectable Stage III NSCLC	NCT03884192	Carcinoma, Non-...	Consolidation S...	18 Years - 75 Years	Shandong Cancer Hospital and Institute
A Study Comparing the Efficacy and Safety Between IBI308 and Docetaxel in Patients With Advanced or Metastatic NSCLC	NCT03150875	Non-small Cell ...	IBI308 Docetaxel	18 Years - 75 Years	Innovent Biologics (Suzhou) Co. Ltd.
Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Unresectable Stage III NSCLC	NCT03872661	Lung Cancer Sta...	IBI308 Bevacizumab Pemetrexed Carboplatin Thoracic surger...	18 Years - 75 Years	Sun Yat-sen University
Consolidation Sintilimab After Concurrent Chemoradiation in Patients With Unresectable Stage III NSCLC	NCT03884192	Carcinoma, Non-...	Consolidation S...	18 Years - 75 Years	Shandong Cancer Hospital and Institute

Spots Global Cancer Trial Database for ibi308

Every month we try and update this database with for ibi308 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ibi308

Every month we try and update this database with for ibi308 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ibi308 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.