Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors
- Conditions
- ocally Advanced or Metastatic Disease in Solid TumorsMedDRA version: 25.1Level: PTClassification code: 10033610Term: Pancreatic carcinoma metastatic Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10059333Term: Pancreatic carcinoma stage IVA Class: 10029104MedDRA version: 21.1Level: PTClassification code: 10029522Term: Non-small cell lung cancer stage IV Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10059326Term: Pancreatic carcinoma stage IV Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10071536Term: Head and neck cancer stage IV Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10066490Term: Progression of non-small cell lung cancer Class: 10029104MedDRA version: 21.0Level: PTClassification code: 10010035Term: Colorectal cancer stage IV Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10071537Term: Head and neck cancer stage III Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864
- Registration Number
- CTIS2023-503812-34-00
- Lead Sponsor
- Seagen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 172
Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer, sqNSCLC, or SCCHN that has failed prior lines of systemic treatment as specified and which are not candidates for standard therapy. oColorectal Cancer (closed to enrollment) oNSCLC(closed to enrollment) oExocrine pancreatic adenocarcinoma(closed to enrollment) oSCCHN: Part C(closed to enrollment) Part E: Patients with SCCHN must have experienced disease progression on or after their most recent systemic therapy. Patients should have received no more than 1 or 2 systemic lines of therapy in the recurrent/metastatic setting as specified below. Maintenance therapy should not be counted as a separate line of therapy. Patients must have received one of the following: oA platinum-based regimen in combination with a PD-1/PD-L1 inhibitor in the first-line recurrent/metastatic setting. No more than 1 prior line of therapy in the recurrent/metastatic setting. oA platinum-based regimen in the first-line setting followed by a PD 1/PD L1 inhibitor (as monotherapy or in combination) in the second-line setting. No more than 2 prior lines of therapy in the recurrent/metastatic setting. oA PD-1/PD-L1 inhibitor in the first-line setting followed by a platinum therapy in the second-line setting. No more than 2 prior lines of therapy in the recurrent/metastatic setting. oTreatment with platinum therapy given as part of a multimodal therapy in the curative setting and experienced recurrence/progression within 6 months of the last dose followed by treatment with a PD-1/PD-L1 inhibitor (as monotherapy or in combination). No other lines of therapy prior to receiving study drug. China will participate in Part E only., Measurable disease according to RECIST v1.1 as assessed by the investigator. oA minimum of one non-nodal lesion =10 mm in the longest diameter from a non-irradiated area. If target lesion(s) are located within previously irradiated area only, the patient can be enrolled only if there has been demonstrated progression in the in field lesion and upon approval of the sponsor's medical monitor. OR oLymph node lesion = 15mm in the shortest diameter from a non-irradiated area. oPart D, F and G: Part D is closed to enrollment. Part F and Part G will enroll only patients with SCCHN. · Patients with SCCHN must have received no previous systemic therapy for recurrent or metastatic disease with the exception of systemic therapy completed >6 months prior, if given as part of multimodal treatment for locally advanced disease in the curative setting. • Part D only: oPatients with NSCLC must have histologically or cytologically documented squamous cell NSCLC and must have received no previous systemic therapy for metastatic disease or radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of study drug. oPD-L1 biomarker expression from IHC analysis should be available oPatients with SCCHN must have a CPS =1 to be eligible for the cohorts testing tisotumab vedotin in combination with pembrolizumab. Patients with sqNSCLC must have a TPS =1% to be enrolled to cohorts testing tisotumab vedotin in combination with pembrolizumab. • Part F only: oPatients must have CPS =1 by local PD-L1 IHC assay to be eligible for enrollment. Retrospective PD-L1 central testing is not required for enrollment. Patients must be able to submit a tissue sample for retrospective PD L1 testing. Tissue may be fresh biopsy or archival, collected within 2 years of Cycle 1
Patients with primary neuroendocrine or sarcomatoid histologies. For SCCHN, patients may not have a primary site of nasopharynx (regardless of histology or salivary gland)., Uncontrolled tumor-related pain, Inflammatory lung disease, including moderate and severe asthma. Patients with chronic obstructive pulmonary disease are allowed if not requiring systemic steroids and long-term oxygen, Medications or treatment regimens: oTherapeutic anti-coagulation therapy is permitted If the patient is no longer being actively titrated for anti-coagulation. For oral anticoagulation therapy, patients must be on steady doses for at least 4 weeks prior to first dose of study drug. oChronic prophylactic treatment with ASA (e.g., aspirin) in combination with other anti-coagulation therapy is prohibited. oCumulative dose of corticosteroid =150 mg (prednisone or equivalent doses of corticosteroids) within 2 weeks of first tisotumab vedotin administration is prohibited., Surgery/procedures: Major surgical procedure (defined as surgery requiring inpatient hospitalization of at least 48 hours) within 4 weeks or excisional biopsy within 7 days prior to first study drug administration. Patients who have planned major surgery during the treatment period must be excluded from the trial, Received a live vaccine within 30 days prior to first dose of trial treatment. Examples include in page 57 of Protocol. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed, Peripheral neuropathy Grade =2, Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parental hydration and/or nutrition, Prior therapy: oPrior treatment with MMAE-derived drugs. oAt least 42 days must have elapsed from last administration of chemoradiotherapy or radiotherapy. Patients must have recovered from all radiation-related toxicities. Palliative radiotherapy within the previous 42 days may be allowed upon discussion with sponsor´s medical team/designee oSmall molecules, chemotherapy, immunotherapy, biologics, experimental agents, or other antitumor therapy within 21 days prior to first administration of study drug. If underlying disease is progressing on treatment, patients may enroll within 21 days upon approval of sponsor's medical monitor. Patients must have recovered from all related toxicities, Uncontrolled Grade 3 or higher (per the NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to first dose of tisotumab vedotin. Routine antimicrobial prophylaxis is permitted, Seropositivity of human immunodeficiency virus; hepatitis B (defined as Hepatitis B surface antigen detected) or known active hepatitis C virus (defined as HCV RNA [qualitative] detected) infection. Part D, F, and G Only: Received prior therapy with an anti–PD-1, anti–PD-L1, or anti–PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor Other exclusion Criteria found in Protocol, Known past or current coagulation defects leading to an increased risk of bleeding; diffuse alveolar hemorrhage from vasculitis; known bleeding diathesis; ongoing major bleeding; trauma with increased risk of lifethreatening bleeding or history of severe head trauma or intracranial surgery within 8 weeks of trial entry, Clinically significant cardiac disease; medical history of congestive heart failure (Grade
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method