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NCT ID: NCT05757973 Approved for marketing - Clinical trials for Relapsed or Refractory Multiple Myeloma

Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this pre-approval access program is to give talquetamab monotherapy (treatment with single drug) to participants with relapsed or refractory multiple myeloma (a type of cancer that begins in plasma cells [white blood cells that produce antibodies] which has returned or difficult to treat) who have relapsed on or are refractory to all locally available and clinically appropriate treatment and who are not eligible for a clinical trial.

NCT ID: NCT05733650 Approved for marketing - Clinical trials for Large B-cell Lymphoma

Expanded Access Program for Epcoritamab

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this program is to provide investigational epcoritamab, an antibody also known as GEN3013 (DuoBody-CD3xCD20), in an expanded access setting for eligible patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) who have a high unmet medical need with no other treatment options. It is a requirement that patients do not qualify for an ongoing epcoritamab clinical program or are unable to participate due to logistical reasons. Access to investigational epcoritamab can be requested by contacting preapprovalaccessprograms@genmab.com.

NCT ID: NCT05463939 Approved for marketing - Clinical trials for Relapsed or Refractory Multiple Myeloma

Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this expanded access treatment protocol is to provide patients access to teclistamab prior to market authorization. The program is limited to patients with relapsed or refractory multiple myeloma who have exhausted all treatment options available as local standard of care and who are not eligible for a teclistamab clinical trial.

NCT ID: NCT05401214 Approved for marketing - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this pre-approval access is to provide Niraparib plus Abiraterone Acetate (Nira/AA combination) in the treatment of (a) participant(s) with first line metastatic castration-resistant prostate cancer with specific Homologous Recombination Repair (HRR) gene alterations.

NCT ID: NCT05345678 Approved for marketing - Clinical trials for Unresectable Hepatocellular Carcinoma

Himalaya Early Access Program

Start date: n/a
Phase:
Study type: Expanded Access

To provide early access (i.e., before marketing authorisation) to tremelimumab 300 mg IV administered once on Day 1 of Cycle 1 plus durvalumab 1500 mg IV followed by durvalumab 1500 mg IV Q4W monotherapy in patients with unresectable HCC.

NCT ID: NCT04599712 Approved for marketing - Clinical trials for Metastatic Non-Small Cell Lung Cancer

Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung Cancer

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this expanded access program (EAP) is to provide amivantamab for the treatment of participants with metastatic non-small cell lung cancer who have epidermal growth factor receptor exon 20 insertion mutations, and whose disease has progressed during or after current standard of care platinum-based chemotherapy. This intermediate EAP may be considered for individuals with serious/life-threatening diseases or conditions, where there are no alternative treatments or where individuals have progressed following standard of care.

NCT ID: NCT04534322 Approved for marketing - Clinical trials for Relapsed and/or Refractory Multiple Myeloma

Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma

sEAPort
Start date: n/a
Phase:
Study type: Expanded Access

To provide early treatment access and evaluate the safety of melflufen and dexamethasone in patients with triple class refractory (TCR) multiple myeloma (MM).

NCT ID: NCT04483531 Approved for marketing - Clinical trials for Progressive Familial Intrahepatic Cholestasis

Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis

Start date: n/a
Phase:
Study type: Expanded Access

To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for PEDFIC 2; 2) Are not able to get to a PEDFIC 2 site for geographical reasons, and 3) Do meet the eligibility criteria for PEDFIC 2 after recruitment has been completed

NCT ID: NCT04320693 Approved for marketing - Clinical trials for Metastatic Triple-Negative Breast Carcinoma

Expanded Access for IMMU-132

Start date: n/a
Phase:
Study type: Expanded Access

This is an expanded access program (EAP) for eligible participants designed to provide access to IMMU-132.

NCT ID: NCT04162756 Approved for marketing - Clinical trials for Relapse/Refractory Mantle Cell Lymphoma

Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies

ZUMA-18
Start date: n/a
Phase:
Study type: Expanded Access

The primary objectives of this study are: Cohort 1: to provide access to brexucabtagene autoleucel (KTE-X19) for individuals with relapsed or refractory (r/r) mantle cell lymphoma (MCL) until KTE-X19 is commercially available Cohort 2: To provide access to KTE-X19 for individuals with r/r MCL whose commercially manufactured product did not meet commercial release specification(s)