Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Antibodies

Immunomodulating Agents

Immunoconjugates

Immunoglobulins

Proteasome Inhibitors

Immunologic Factors

Dose and schedule: belantamab mafodotin 2.5 mg/kg IV Q3weeks

Belantamab mafodotin (GSK2857916) anti-BCMA-immunoconjugate

US GSK Clinical Trials Call Center

GSK Clinical Trials

Compassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with refractory/relapsing multiple myeloma

Belantamab mafodotin (GSK2857916) is a humanized IgG1 monoclonal immunoconjugate that binds specifically to B-Cell Maturation Antigen. This program is intended to provide access to belantamab mafodotin in patients with Relapsed/Refractory Multiple Myeloma (MM) and who are refractory to an anti-CD38 antibody (e.g. daratumumab) alone or in combination, and to an immunomodulatory drug (IMiD) (i.e., lenalidomide or pomalidomide), and to a proteasome inhibitor (PI) (i.e., bortezomib, ixazomib or carfilzomib). Patients considering this access program should have no other therapeutic option, and not eligible for other clinical trials. US patients who have been treated through the REMS program are eligible to enroll in this program.

Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in Multiple Myeloma

Expanded Access Program for Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma Who Are Refractory to a Proteasome Inhibitor, and an Immunomodulatory Agent, and an Anti-CD38 Antibody

GlaxoSmithKline

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Antineoplastic Agents

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Oral capsules: 4 milligrams (mg) and 10 mg

This is an Expanded Access Program to make lenvatinib available to participants with radioiodine-refractory differentiated thyroid cancer in Brazil. Participants who have no other treatment options available, and who, in the opinion and clinical judgment of the treating physician, would benefit from treatment with lenvatinib will be enrolled. This is a multicenter, open-label program consisting of 2 phases: a 28-day pretreatment phase (including screening) and a treatment phase. Treatment will be provided as long as there is a clinical benefit based on tumor assessments performed according to the center's standard of care and the judgment of the participant's treating physician.

Expanded Access Program With Lenvatinib for the Treatment of Differentiated Thyroid Cancer in Brazil

Expanded Access Program With Lenvatinib for the Treatment of Radioiodine-Refractory Differentiated Thyroid Cancer in Brazil

Eisai Inc.

Cholangiocarcinoma

Klatskin Tumor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Bile Duct Cancer

Anti-Inflammatory Agents

ABC294640

Mark L Levitt, MD, PhD

Vered Katz Ben-Yair, MSc

This is an expanded access program (EAP) for eligible participants who do not qualify for participation in, or who are otherwise unable to access, the ongoing clinical trial ABC-108. This program is designed to provide access to ABC294640 (Yeliva ®) for treatment of cholangiocarcinoma (CCA) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. An oncologist must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)

Expanded Access to ABC-108, A Phase IIA Study of ABC294640 in the Treatment of Patients With Advanced,Unresectable Intra-hepatic, Perihilar and Extra-Hepatic Cholangiocarcinoma

RedHill Biopharma Limited

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Capmatinib

CapmATU study will evaluate time to treatment failure, progression-free survival, overall survival, best response and safety in patients with advanced MET-dysregulated non-small cell lung cancer who received capmatinib as part of an expanded access program. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

Capmatinib has been approved in the USA and Japan. In France, a compassionate use for capmatinib has been approved in June 2019 for patients with MET alterations, including METex14 mutations and MET amplification. In March 2021, 204 patients are or have been treated with compassionate use capmatinib as part of this program, most of them (n=175) harboring a METex14 mutation.

So far, data on activity and safety of new-generation MET TKIs are still sparse and only based on prospective clinical studies. The CapmATU study is a unique opportunity to describe patients' characteristics and outcomes, and confirm effectiveness of capmatinib in a large cohort of METex14 NSCLC. Moreover, it will provide original real-world evidence (RWE). RWE can be used in oncology to further characterize the safety and efficacy of drugs in the post-marketing setting. This may include confirmation of clinical benefit for regulatory purposes, expansion of labeling claims to new indications, testing of alternate doses and schedules of drugs, and assessment of drug activity in biomarker-defined subgroups and other special populations. This may be even more important in the context of METex14 NSCLC patients since no real world data with new generation MET TKIs have been reported so far. Indeed, this study will allow to determine whether the antitumor activity of capmatinib reported in the GEOMETRY-MONO-1 study can be observed in less selected patients. Given the older age and associated comorbidities of METex14 NSCLC patients, most of them may not be eligible to a clinical trial, thus emphasizing the need for real-world evidence. Finally, the biological part of this study (CapmATU-BIO) will offer opportunity to identify biomarkers of sensitivity or acquired resistance to capmatinib, which is a poorly explored field of research so far.

In this context, the objectives of this non-interventional retrospective French population-base study are to describe the characteristics of patients with MET-dysregulated NSCLC, assess effectiveness and safety of capmatinib in these patients and identify biomarkers of benefit from capmatinib.

RW Effectiveness of Capmatinib in Advanced MET-dysregulated NSCLC Included in the French Compassionate Use Program (ATU)

Real World Effectiveness of Capmatinib in Patients With Advanced MET-dysregulated NSCLC Included in the French Compassionate Use Program (ATU)

time to treatment failure in patients with advanced NSCLC harboring a METex14 mutation receiving capmatinib as part of the French compassionate use program (ATU)

Novartis

Intergroupe Francophone de Cancerologie Thoracique

Symptoms and General Pathology

Emergencies

6 mg/kg intravenous infusion Q3W (on Day 1 of each 21-day cycle)

Datopotamab deruxtecan

Contact for Program Information

Principal Investigator

Global Medical Affairs

The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to Dato-DXd for eligible patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who, in their treating physician's opinion, have an unmet clinical need, are unlikely to obtain optimal benefit from currently approved and commercially available drugs, and who cannot enter a suitable clinical trial.

This is a Medical Access Program that will be available to adult patients in the USA with previously treated advanced or metastatic nonsquamous NSCLC who have no suitable treatment options and are not able to enter a clinical trial.

Patients enrolled in the Medical Access Program can continue treatment until any of the following occurs:

* Disease progression
* Unacceptable toxicity
* The benefit-risk no longer favors the individual
* Dato-DXd becomes commercially available and reimbursement is approved
* The patient chooses to discontinue treatment
* Withdrawal of consent
* Pregnancy
* Physician discretion
* Death

Patients enrolled in the Medical Access Program have an option to participate in collection of safety-focused clinical practice data. This will contribute towards better understanding of the clinical experience of treatment with Dato-DXd. Participation in this optional data collection will have no bearing on receipt of treatment.

Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients

Medical Access Program for Datopotamab Deruxtecan (Dato-DXd, DS-1062a)

AstraZeneca

Daiichi Sankyo

Infections

Carcinoma, Merkel Cell

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Avelumab

Antineoplastic Agents, Immunological

Avelumab should be administered intravenously as per the recommended dose. Administration of Avelumab should continue according to the recommended schedule until disease progression or unacceptable toxicity.

Expanded access to Avelumab solution for infusion will be made available for adult patients with mMCC whose disease has progressed after receiving at least one prior chemotherapy.

Expanded Access to Avelumab for Treatment of Metastatic Merkel Cell Carcinoma (mMCC)

Temporary Authorization for Use (ATU) to Avelumab for Treatment of Adult Patients With Metastatic Merkel Cell Carcinoma (mMCC)

Pfizer

Merck KGaA, Darmstadt, Germany

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in Multiple Myeloma	NCT03763370	Multiple Myelom...	Belantamab mafo...	18 Years -	GlaxoSmithKline
Expanded Access Program With Lenvatinib for the Treatment of Differentiated Thyroid Cancer in Brazil	NCT03533361	Thyroid Cancer	Lenvatinib	18 Years -	Eisai Inc.
Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)	NCT03414489	Cholangiocarcin... Cholangiocarcin... Cholangiocarcin... Cholangiocarcin... Cholangiocarcin...	ABC294640	18 Years -	RedHill Biopharma Limited
Expanded Access Program With Lenvatinib for the Treatment of Differentiated Thyroid Cancer in Brazil	NCT03533361	Thyroid Cancer	Lenvatinib	18 Years -	Eisai Inc.
RW Effectiveness of Capmatinib in Advanced MET-dysregulated NSCLC Included in the French Compassionate Use Program (ATU)	NCT05154344	MET Alterations Non Small Cell ... METex14 Mutatio...	Capmatinib	18 Years -	Intergroupe Francophone de Cancerologie Thoracique
RW Effectiveness of Capmatinib in Advanced MET-dysregulated NSCLC Included in the French Compassionate Use Program (ATU)	NCT05154344	MET Alterations Non Small Cell ... METex14 Mutatio...	Capmatinib	18 Years -	Intergroupe Francophone de Cancerologie Thoracique
Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients	NCT06279728	Advanced Non-Sm... Metastatic Non ...	Datopotamab der...	18 Years -	Daiichi Sankyo
Expanded Access to Avelumab for Treatment of Metastatic Merkel Cell Carcinoma (mMCC)	NCT03089658	Metastatic Merk...	Avelumab	18 Years -	Merck KGaA, Darmstadt, Germany
Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)	NCT03414489	Cholangiocarcin... Cholangiocarcin... Cholangiocarcin... Cholangiocarcin... Cholangiocarcin...	ABC294640	18 Years -	RedHill Biopharma Limited
Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in Multiple Myeloma	NCT03763370	Multiple Myelom...	Belantamab mafo...	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for expanded access program