Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04999202
Status:
TERMINATED
Last Update Posted:
2025-02-10
First Post:
2021-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in Combination With the Treatment Pembrolizumab is, How This Combination Affects the Body, the Maximum Amount That Can be Given, How it Moves Into, Through and Out of the Body and Its Action Against Advanced Solid Cancers in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'whyStopped': 'Last patient ongoing on treatment ended the study on 20th January 2025. Hence, the end of study was reached as defined in the protocol.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2021-08-05', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of TEAEs including TESAEs', 'timeFrame': 'After first administration of BAY2416964 in combination with pembrolizumab up to 90 days after the last dose of BAY2416964 in combination with pembrolizumab', 'description': 'TEAEs: treatment-emergent adverse events TESAEs: treatment-emergent serious adverse events'}, {'measure': 'The severity of TEAEs including TESAEs', 'timeFrame': 'After first administration of BAY2416964 in combination with pembrolizumab up to 90 days after the last dose of BAY2416964 in combination with pembrolizumab'}, {'measure': 'Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2416964', 'timeFrame': 'Cycle 1 (21 days) in dose escalation', 'description': 'The MTD/MAD is the dose level that can be safely given, defined as the occurrence of dose-limiting toxicities (DLTs) below a certain threshold.'}], 'secondaryOutcomes': [{'measure': 'Cmax of BAY2416964 after single-dose in Cycle 1', 'timeFrame': 'Cycle 1 Day 1 (1 cycle is 21 days)'}, {'measure': 'Cmax of BAY2416964 after multiple-dose in Cycle 1', 'timeFrame': 'Cycle 1 Day 15 (1 cycle is 21 days)'}, {'measure': 'AUC(0-t) (t depend on the dosing regimen) of BAY2416964 after single-dose in Cycle 1', 'timeFrame': 'Cycle 1 Day 1 (1 cycle is 21 days)'}, {'measure': 'AUC(0-t) (t depend on the dosing regimen) of BAY2416964 after multiple-dose in Cycle 1', 'timeFrame': 'Cycle 1 Day 15 (1 cycle is 21 days)'}, {'measure': 'Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)', 'timeFrame': 'At the end of Cycle 2 (-7 days, each cycle is 21 days), Cycle 4 (-7 days) and at the end of every third cycle (-7 days) from Cycle 5 onwards', 'description': 'ORR will be evaluated using RECIST 1.1 by investigator assessment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer (NSCLC)', 'Head and neck squamous cell carcinoma (HNSCC)', 'Urothelial Cancer', 'Advanced cancer', 'Immunotherapy', 'Immuno oncology', 'Aryl Hydrocarbon Receptor inhibitor(AhRi)', 'Aryl Hydrocarbon Receptor', 'Pembrolizumab', 'aPD1', 'Checkpoint inhibitor'], 'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.'}]}, 'descriptionModule': {'briefSummary': "Researchers are looking for a better way to treat advanced solid cancers including head and neck cancer, lung cancer and bladder cancer.\n\nIn some people with cancer a protein called Aryl Hydrocarbon Receptor (AhR) can prevent immune cells from fighting tumor cells. The study drug, BAY 2416964, is a small molecule which blocks the AhR allowing the body to use its immune response against the cancer cells. Researchers think that BAY 2416964 given together with a cancer treatment called pembrolizumab may help shrink tumors in people with cancer.\n\nThe main aims of this study are to find for BAY 2416964 in combination with pembrolizumab,\n\n* how safe this drug combination is\n* how it affects the body (also referred to as tolerability)\n* the highest amount of BAY 2416964 that can be given in combination with pembrolizumab without too many side effects.\n\nThe researchers will also study the action of BAY 2416964 in combination with pembrolizumab against the cancer.\n\nThe participants in this study will get BAY 2416964 and pembrolizumab. BAY 2416964 will be given by mouth. Pembrolizumab will be given as an intravenous (IV) infusion. An IV infusion is given through a needle into a vein.\n\nThis study will have two parts. The first part will help find the most appropriate dose that can be given in the second part.\n\nEach participant of the first, so called dose escalation part, will be assigned to one specific dose group for BAY 2416964. The amount of BAY 2416964 that is given changes step-wise from one group to the next. The dose of pembrolizumab will always be the same.\n\nThe participants of the second, so called dose expansion part, will receive the most appropriate dose of BAY 2416964 found in the first part.\n\nDuring the study, the participants will receive the treatment in 3-week periods called cycles. In each cycle, the participants will in general get pembrolizumab once and BAY 2416964 in a daily schedule. These 3-week cycles will be repeated throughout the trial. The participants can take the study treatment until their cancer gets worse, until they have medical problems, or until they leave the trial. Participants will have around 4 visits in each cycle. Some of the visits can also be done via phone.\n\nDuring the study, the study doctors and their team will:\n\n* take blood and urine samples\n* check if the participants' cancer has changed in size using computed tomography scans or magnetic resonance imaging scans of the participants' tumors\n* check the participants' overall health\n* ask the participants questions about how they are feeling and what adverse events they are having.\n\nAn adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must be ≥18 years of age inclusive, at the time of signing the informed consent.\n* Participants with following histologically or cytologically confirmed advanced solid tumors that have progressed after treatment with all available therapies for metastatic disease that are known to confer clinically meaningful benefit, or are intolerant to treatment, or refuse standard treatment.\n\n * Dose Escalation: all solid tumor types\n * Tumor type-specific Expansion cohorts:\n\n * NSCLC\n * HNSCC with primary location in oropharynx, oral cavity, hypopharynx or larynx\n * Urothelial Cancer\n* Participants must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies.\n* Have measurable disease per RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n\nExclusion Criteria:\n\n* Severe (Common terminology criteria for adverse events (CTCAE) v.5 Grade ≥ 3) infections within 4 weeks before the first study intervention administration\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy\n* Has active Central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n* Cardiac disease as specified in the protocol'}, 'identificationModule': {'nctId': 'NCT04999202', 'briefTitle': 'A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in Combination With the Treatment Pembrolizumab is, How This Combination Affects the Body, the Maximum Amount That Can be Given, How it Moves Into, Through and Out of the Body and Its Action Against Advanced Solid Cancers in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Open-label, Phase 1b, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Efficacy of the Aryl Hydrocarbon Receptor Inhibitor (AhRi) BAY 2416964 in Combination With Pembrolizumab in Participants With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '21343'}, 'secondaryIdInfos': [{'id': 'PN-A61', 'type': 'OTHER', 'domain': 'Merck'}, {'id': '2023-503547-33-00', 'type': 'OTHER', 'domain': 'CTIS (EU)'}, {'id': '2020-003547-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose escalation of BAY2416964', 'description': 'Six dose levels of BAY 2416964 (as determined in the first in human mono-therapy study of BAY2416964) are planned in combination with standard dose Pembrolizumab.', 'interventionNames': ['Drug: BAY2416964', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose expansion of BAY2416964 in tumor type specific cohort', 'description': 'To determine the RP2D of BAY2416964 in combination therapy with pembrolizumab. Participants will be enrolled in up to 3 tumor type-specific cohorts including relapsed/refractory non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and urothelial cancer.', 'interventionNames': ['Drug: BAY2416964', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'BAY2416964', 'type': 'DRUG', 'description': 'Oral, twice or three times daily', 'armGroupLabels': ['Dose escalation of BAY2416964']}, {'name': 'BAY2416964', 'type': 'DRUG', 'description': 'The highest dose determined safe in combination with pembrolizumab in the dose escalation part or a lower dose. More than one dose may be explored in the dose expansion.', 'armGroupLabels': ['Dose expansion of BAY2416964 in tumor type specific cohort']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Administered as a dose of 200 mg using a 30-minute IV infusion every 3 weeks', 'armGroupLabels': ['Dose escalation of BAY2416964', 'Dose expansion of BAY2416964 in tumor type specific cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32701', 'city': 'Altamonte Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 28.66111, 'lon': -81.36562}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists & Research Institute', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology- Austin Midtown', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Specialists, PC', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'facility': 'IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Sperimentazioni Cliniche', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '20133', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20141', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie Innovative', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20162', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'ASST Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital Medical Centre', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': 'BT12 7AB', 'city': 'Belfast', 'state': 'North Ireland', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'NE7 7DN', 'city': 'Newcastle', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will later be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nInterested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}