Phase
Condition
Neoplasms
Treatment
Livmoniplimab
Budigalimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For Dose Escalation only: Participants with an advanced solid tumor who areconsidered refractory to or intolerant of all existing therapy(ies) known to providea clinical benefit for their condition. Additionally, participants who have beenoffered standard therapies and refused, or who are considered ineligible forstandard therapies, may be eligible for this study on a case-by-case basis, afterdiscussion with and agreement from the sponsor. Participants with pancreaticadenocarcinoma, urothelial cancer (UC), hepatocellular carcinoma (HCC), or head andneck squamous cell carcinoma (HNSCC) who are being considered for the doseescalation cohorts must also meet the histology specific eligibility criteriadescribed below for dose expansion.
For Dose Expansion only participants must meet criteria specific to the type ofcancer:
Pancreatic adenocarcinoma and have disease progression during or after 1systemic therapy (gemcitabine monotherapy or in combination with other agents,FOLFIRINOX [or another regimen including both 5-fluorouracil and oxaliplatin],capecitabine monotherapy or in combination with other agents) administered inthe adjuvant, locally advanced, or metastatic setting. If the therapy was usedin an adjuvant setting, disease progression must have occurred within 6 monthsof completing adjuvant therapy.
UC of the bladder and urinary tract and must have progressed followingtreatment with:
Cohort 4: A platinum-based regimen (administered in any line of therapy) and aprogrammed death 1/programmed death ligand 1 (PD1/PDL1) antagonist administeredin the recurrent or metastatic setting (progression following a PD1/PDL1antagonist is defined as unequivocal progression on or within 3 months of thelast dose of anti-PD1 or anti-PDL1 therapy).
Cohort 11: One or more prior line of therapy in the locally advanced ormetastatic setting. Participant must have experienced radiographic progressionor relapse during or after a CPI (anti-PD1 or anti-PD-L1) for locally advancedor metastatic disease.
HCC and must have disease progression during or after 1 prior line of systemictherapy.
HNSCC (arising from the oral cavity, oropharynx, hypopharynx, or larynx) andmust have progressed following treatment with platinum-based regimen (administered in any line of therapy) and a PD1/PDL1 antagonist administered inthe recurrent or metastatic setting (progression following a PD1/PDL1antagonist is defined as unequivocal progression on or within 3 months of thelast dose of anti-PD1 or anti-PDL1 therapy).
Microsatellite stable colorectal cancer (MSS-CRC) [unselected] participantswith microsatellite stable or mismatch repair proficient colorectaladenocarcinoma (as determined by polymerase chain reaction (PCR)/Next-Generation sequencing (NGS) or immunohistochemistry (IHC),respectively) who have received 1-2 prior chemotherapy regimens.
Non-small cell lung cancer (NSCLC) relapsed/refractory (R/R): Participants withhistologically or cytologically confirmed advanced or metastatic NSCLC who havereceived 1 prior line of chemotherapy and 1 prior anti-PD-(L)1 antibody,administered either concurrently or sequentially in the metastatic setting.
MSS-CRC (CMS4 enriched): Participants with microsatellite stable or mismatchrepair proficient colorectal adenocarcinoma who have received priorfluorouracil-based combination chemotherapy regimens including oxaliplatin andirinotecan (with or without VEGF and/or EGFR targeted agents) and with a CMS4subtype as determined by NGS of tumor biopsies. Archival tissue must besubmitted for assessment of CMS4 subtype status during prescreening.Participants must have progressed on or refused available standard of caretherapies. Additionally, participant who are considered not appropriate orineligible for available standard of care therapies per investigator assessmentwill be eligible for this study.
Ovarian granulosa (OG) cell tumor: Participants with histologically confirmedadvanced nonresectable or metastatic adult granulosa cell tumor of the ovarythat is not amenable to curative intent surgery or radiation. Additionally,there is documentation of radiological evidence of relapse after at least 1line of systemic chemotherapy.
Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0to 1.
Participant has adequate bone marrow, renal, hepatic, and coagulation function.
Must have a viral status consistent with the requirements described in the protocolspecific to type of cancer and stage of study (Dose Escalation or Dose Expansion).
Exclusion
Exclusion Criteria:
For Dose Expansion only:
Participants with HCC, pancreatic adenocarcinoma, or MSS-CRC having priorexposure to a prior PD-1/PD-L1 antagonist in any line of therapy.
Participants (except for participants with urothelial cancer or HNSCC) who havehad prior exposure to immunotherapies as listed in the protocol.
Has received anticancer therapy including chemotherapy, immunotherapy, radiationtherapy, biologic, herbal therapy, or any investigational therapy within a period of 5 half-lives or 28 days (whichever is shorter), prior to the first dose of the studydrug.
Participant has unresolved AEs > Grade 1 from prior anticancer therapy except foralopecia.
Has a history of primary immunodeficiency, bone marrow transplantation, solid organtransplantation, or previous clinical diagnosis of tuberculosis.
Has a known uncontrolled metastases to the central nervous system (with certainexceptions).
Current or prior use of immunosuppressive medication within 14 days prior to thefirst dose of the study drug.
Has clinically significant uncontrolled condition(s).
History of inflammatory bowel disease, interstitial lung disease or pneumonitis,myocarditis, Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reactionwith eosinophilia and systemic symptoms (DRESS).
Live vaccine administration <= 28 days prior to the first dose of study drug.
Study Design
Connect with a study center
Chris O'Brien Lifehouse /ID# 213236
Camperdown, New South Wales 2050
AustraliaSite Not Available
Icon Cancer Centre /ID# 224961
South Brisbane, Queensland 4101
AustraliaSite Not Available
Cliniques Universitaires UCL Saint-Luc /ID# 218466
Bruxelles, Bruxelles-Capitale 1200
BelgiumSite Not Available
Cliniques Universitaires UCL Saint-Luc /ID# 218466
Woluwe-Saint-Lambert, Bruxelles-Capitale 1200
BelgiumSite Not Available
UCL Saint-Luc /ID# 218466
Woluwe-Saint-Lambert, Bruxelles-Capitale 1200
BelgiumActive - Recruiting
Princess Margaret Cancer Centre /ID# 209423
Toronto, Ontario M5G 2M9
CanadaCompleted
University Health Network_Princess Margaret Cancer Centre /ID# 209423
Toronto, Ontario M5G 2M9
CanadaSite Not Available
CHU Toulouse - Hopital Purpan /ID# 218667
TOULOUSE Cedex 9, Haute-Garonne 31059
FranceSite Not Available
Hopital Universitaire Purpan /ID# 218667
Toulouse, Haute-Garonne 31059
FranceSite Not Available
Centre Leon Berard /ID# 218515
Lyon CEDEX 08, Rhone 69373
FranceSite Not Available
Institut Gustave Roussy /ID# 218668
Villejuif, Val-de-Marne 94800
FranceSite Not Available
Institut Gustave Roussy /ID# 218668
Villejuif Cedex, Val-de-Marne 94805
FranceSite Not Available
Centre Jean Perrin /ID# 218669
Clermont Ferrand, 63011
FranceSite Not Available
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung /ID# 269587
Essen, Nordrhein-Westfalen 45136
GermanySite Not Available
Rambam Health Care Campus /ID# 222198
Haifa, H_efa 3109601
IsraelSite Not Available
The Chaim Sheba Medical Center /ID# 209037
Ramat Gan, Tel-Aviv 5265601
IsraelSite Not Available
Tel Aviv Sourasky Medical Center /ID# 222199
Tel Aviv, Tel-Aviv 6423906
IsraelSite Not Available
Tel Aviv Sourasky Medical Center /ID# 222199
Tel Aviv-Yafo, Tel-Aviv 6423906
IsraelSite Not Available
Rabin Medical Center /ID# 258479
Haifa, 4941492
IsraelActive - Recruiting
Hadassah Medical Center /ID# 257918
Jerusalem, 9112001
IsraelActive - Recruiting
Hadassah Medical Center-Hebrew University /ID# 257918
Jerusalem, 91120
IsraelSite Not Available
Rabin Medical Center /ID# 258479
Petah Tikva, 4941492
IsraelSite Not Available
Istituto Europeo Di Oncologia /Id# 266053
Milan, Milano 20121
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 266054
Rome, Roma 00168
ItalySite Not Available
National Cancer Center Hospital East /ID# 224808
Kashiwa-shi, Chiba 277-8577
JapanSite Not Available
Hyogo Cancer Center /ID# 272553
Akashi-shi, Hyogo 673-8558
JapanSite Not Available
National Cancer Center Hospital /ID# 209421
Chuo-ku, Tokyo 104-0045
JapanSite Not Available
Gachon University Gil Medical Center /ID# 257572
Incheon, Gyeonggido 21565
Korea, Republic ofSite Not Available
Gachon University Gil Medical Center /ID# 257572
남동구, Gyeonggido 21565
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital /ID# 257573
Hwasun-gun, Jeonranamdo 58128
Korea, Republic ofSite Not Available
Asan Medical Center /ID# 266799
Seoul, Seoul Teugbyeolsi 05505
Korea, Republic ofSite Not Available
Korea University Anam Hospital /ID# 257574
Seoul, Seoul Teugbyeolsi 02841
Korea, Republic ofSite Not Available
Samsung Medical Center /ID# 265865
Seoul, Seoul Teugbyeolsi 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital /ID# 218513
Seoul, Seoul Teugbyeolsi 03080
Korea, Republic ofSite Not Available
Yonsei University Health System Severance Hospital /ID# 218512
Seoul, 03722
Korea, Republic ofSite Not Available
Instytut Centrum Zdrowia Matki Polki /ID# 266324
Lodz, Lodzkie 93-338
PolandSite Not Available
Jagiellonskie Centrum Innowacji Sp. z o.o. /ID# 266194
Krakow, Malopolskie 30-348
PolandSite Not Available
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 266147
Warszawa, Mazowieckie 02-781
PolandSite Not Available
Pan American Center for Oncology Trials, LLC /ID# 217475
Rio Piedras, 00935
Puerto RicoSite Not Available
Clinica Universidad de Navarra - Pamplona /ID# 266632
Pamplona, Navarra 31008
SpainSite Not Available
Hospital Clinic de Barcelona /ID# 221106
Barcelona, 08036
SpainSite Not Available
Hospital Universitari Vall d'Hebron /ID# 265290
Barcelona, 08035
SpainSite Not Available
Clinica Universidad de Navarra - Madrid /ID# 265299
Madrid, 28027
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz /ID# 220928
Madrid, 28040
SpainSite Not Available
Hospital Universitario HM Sanchinarro /ID# 265294
Madrid, 28050
SpainSite Not Available
Hospital Universitario Ramón y Cajal /ID# 265298
Madrid, 28034
SpainSite Not Available
Hospital Clinico Universitario de Valencia /ID# 221107
Valencia, 46010
SpainSite Not Available
Hosp Clin Univ de Valencia /ID# 221107
València, 46010
SpainSite Not Available
Kaohsiung Chang Gung Memorial Hospital /ID# 265560
Kaohsiung City, Kaohsiung 833
TaiwanSite Not Available
National Taiwan University Hospital /ID# 218490
Taipei City, Taipei 100
TaiwanSite Not Available
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257634
Kaohsiung, 807
TaiwanSite Not Available
China Medical University Hospital /ID# 218492
Taichung, 40447
TaiwanSite Not Available
China Medical University Hospital /ID# 218492
Taichung City, 40447
TaiwanSite Not Available
Taipei Veterans General Hosp /ID# 257635
Taipei, 11217
TaiwanSite Not Available
Linkou Chang Gung Memorial Hospital /ID# 265551
Taoyuan City, 333
TaiwanSite Not Available
Highlands Oncology Group, PA /ID# 218942
Springdale, Arkansas 72762
United StatesSite Not Available
City of Hope National Medical Center /ID# 265620
Duarte, California 91010
United StatesSite Not Available
City of Hope Orange County Lennar Foundation Cancer Center /ID# 270785
Irvine, California 92618
United StatesSite Not Available
Univ California, San Francisco /ID# 221131
San Francisco, California 94143-2204
United StatesSite Not Available
Yale University /ID# 208356
New Haven, Connecticut 06510
United StatesActive - Recruiting
Yale University School of Medicine /ID# 208356
New Haven, Connecticut 06510
United StatesSite Not Available
AdventHealth Celebration /ID# 224860
Celebration, Florida 34747-4970
United StatesSite Not Available
AdventHealth Celebration /ID# 224860
Kissimmee, Florida 34747-4970
United StatesSite Not Available
AdventHealth Cancer Institute - Orlando /ID# 226953
Orlando, Florida 32804
United StatesCompleted
Duplicate_AdventHealth Cancer Institute - Orlando /ID# 226953
Orlando, Florida 32804
United StatesSite Not Available
Community Health Network, Inc. /ID# 257032
Indianapolis, Indiana 46250-2042
United StatesSite Not Available
Indiana Univ School Medicine /ID# 208384
Indianapolis, Indiana 46202
United StatesSite Not Available
Univ Michigan Med Ctr /ID# 221129
Ann Arbor, Michigan 48109
United StatesSite Not Available
Washington University-School of Medicine /ID# 259684
Saint Louis, Missouri 63110
United StatesSite Not Available
Intermountain Health West End Clinic Gynecologic Oncology /ID# 266171
Billings, Montana 59106
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai /ID# 264653
New York, New York 10029
United StatesSite Not Available
NYU Langone Medical Center /ID# 209822
New York, New York 10016-6402
United StatesSite Not Available
Carolina BioOncology Institute /ID# 208358
Huntersville, North Carolina 28078
United StatesSite Not Available
The Ohio State University - The James /ID# 217611
Columbus, Ohio 43210-1240
United StatesSite Not Available
Ou Health - Stephenson Cancer Center /ID# 268826
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Sarah Cannon Research Institute (SMO/Network/Consortium) /ID# 264900
Nashville, Tennessee 37203-5755
United StatesSite Not Available
Sarah Cannon Research Institute - Main /ID# 264900
Nashville, Tennessee 37203-5755
United StatesActive - Recruiting
Sarah Cannon Research Institute /ID# 264900
Nashville, Tennessee 37203-5755
United StatesActive - Recruiting
Renovatio clinical /ID# 265109
El Paso, Texas 79915-1803
United StatesSite Not Available
NEXT Oncology /ID# 208930
San Antonio, Texas 78229
United StatesSite Not Available
Renovatio Clinical /ID# 265054
The Woodlands, Texas 77380-3181
United StatesSite Not Available
University of Washington Medical Center /ID# 268854
Seattle, Washington 98195
United StatesSite Not Available
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