- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05238831
SMMART Adaptive Clinical Treatment (ACT) Trial
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT)
Study Overview
Status
Conditions
- Anatomic Stage III Breast Cancer AJCC v8
- Recurrent Ovarian Carcinoma
- Anatomic Stage IV Breast Cancer AJCC v8
- Advanced Malignant Solid Neoplasm
- Advanced Pancreatic Carcinoma
- Stage II Pancreatic Cancer AJCC v8
- Stage III Pancreatic Cancer AJCC v8
- Stage IV Pancreatic Cancer AJCC v8
- Recurrent Breast Carcinoma
- Recurrent Prostate Carcinoma
- Advanced Prostate Carcinoma
- Recurrent Adult Soft Tissue Sarcoma
- Advanced Breast Carcinoma
- Advanced Sarcoma
- Stage III Ovarian Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Advanced Ovarian Carcinoma
Intervention / Treatment
- Drug: Carboplatin
- Other: Quality-of-Life Assessment
- Procedure: Biospecimen Collection
- Drug: Nab-paclitaxel
- Drug: Paclitaxel
- Biological: Bevacizumab
- Drug: Vismodegib
- Drug: Vemurafenib
- Drug: Olaparib
- Biological: Atezolizumab
- Drug: Irinotecan
- Drug: Alpelisib
- Drug: Capecitabine
- Drug: Eribulin
- Drug: Letrozole
- Drug: Anastrozole
- Drug: Cobimetinib
- Procedure: Biopsy
- Drug: Niraparib
- Drug: Vinorelbine
- Drug: Entrectinib
- Drug: Alectinib
- Drug: Palbociclib
- Drug: Fulvestrant
- Biological: Hyaluronidase-zzxf/Pertuzumab/Trastuzumab
- Biological: Pertuzumab
- Biological: Trastuzumab
- Biological: Trastuzumab Emtansine
Detailed Description
PRIMARY OBJECTIVE:
I. Feasibility of utilizing a SMMART-ACT Tumor Board to select personalized advanced cancer treatment plans based on a pre-determined set of drug agents with recommended phase 2 doses (RP2Ds).
SECONDARY OBJECTIVES:
I. Safety and tolerability of assigned ACT intervention per cancer type; II. Preliminary indications of efficacy based on disease-specific responses; and.
III. Estimated survival benefit per cancer type.
EXPLORATORY OBJECTIVES:
I. Durability of a response compared to the most recent therapy on which progression occurred.
II. Changes in ability to conduct activities of daily living (ADL). III. Changes in quality of life (QOL).
IV. Feasibility of SMMART centric assessments of ongoing responses to treatment to identify mechanisms of therapy induced change, per investigator discretion. Such mechanisms may include, but will not be limited to, the following:
IVa. Changes in tumor and tumor ecosystem biology; IVb. Response and resistance to therapy.
OUTLINE:
PRE-SCREENING: Participants undergo a screening biopsy and blood collection for review and assessment of their tumor, utilizing one or more of the SMMART-Clinical Analytics Platform (SMMART-CAP) assays. The clinical assays may be used to provide an optimal and individualized treatment approach which may or may not include a SMMART-ACT treatment regimen.
SMMART-ACT TREATMENT: Prior to enrollment, participants must receive a treatment recommendation, via a SMMART-ACT Tumor Board, that consists of one or more of the pre-defined SMMART-ACT treatment regimen options. Participants are considered enrolled in SMMART-ACT if they receive a targeted SMMART-ACT treatment regimen, which may be administered in monotherapy or in combination with other targeted agents or immunotherapies, chemotherapies, or radiation. A combination treatment plan may include a two-week monotherapy lead-in, followed by a combination treatment regimen. Regardless of overall recommended treatment plan details, each SMMART-ACT study intervention must have an established RP2D that was determined in a prior clinical trial. All participants are required to undergo an On-Treatment Biopsy after two weeks on the first dose of study drug(s), and before starting Cycle 2, regardless of whether the participant is on a monotherapy, monotherapy-induction or combination regimen. Participants will continue to receive the study agent(s) after their On-Treatment Biopsy according to the biopsy results and the results of ongoing safety and clinical assessments. Treatment cycles repeat every 21 to 28 days in the absence of disease progression or unacceptable toxicity. Cycles are determined based on the study agent(s). Upon disease progression, participants are given the option to undergo an additional repeat biopsy.
Participants completing study treatment due to disease progression are followed every 3 months for 1 year, then every 6 months for 5 years. Participants completing study treatment without disease progression are followed every 6-12 weeks for up to 5 years or until disease progression, start of a new therapy, withdrawal from the study, or death, whichever occurs first.
Study Type
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Lara Davis, M.D.
- Phone Number: 503-494-6594
- Email: davisla@ohsu.edu
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
-
Principal Investigator:
- Lara E. Davis
-
Contact:
- Lara E. Davis
- Phone Number: 503-494-6594
- Email: davisla@ohsu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- PRE-SCREENING: Written informed consent prior to any pre-screening activities, study-specific procedures or interventions.
- PRE-SCREENING: At least 18 years of age at time of informed consent. Persons of all gender identities, biological sexes, races, and ethnicities will be included.
- PRE-SCREENING: A diagnosis of advanced sarcoma or advanced prostate, breast, ovarian, or pancreatic cancer. Change in an individual's cancer can be tracked objectively according to the Prostate Cancer Working Group 3 (PCWG3) criteria for prostate cancer, and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria for sarcomas and breast, ovarian, and pancreatic cancers.
PRE-SCREENING: Biospecimen collection, as per institutional standards, must be consented to and collection must be feasible, with the following exceptions for tissue collections:
- Individuals with a prior successful SMMART-CAP tumor tissue sample collected within the last 90 days may be eligible, given that =<1 treatment has been received within =< 90 days of that biopsy.
- PRE-SCREENING: Eastern Cooperative Oncology Group (ECOG) performance status of =< 2.
- PRE-SCREENING: Physician assessed life expectancy of >= 6 months.
- PRIMARY TREATMENT: Documented progression after at least 1 line of prior therapy for advanced disease. If recurrence occurred within 6 months of the last dose of an adjuvant/neoadjuvant therapy, that adjuvant/neoadjuvant therapy will count as 1 line of therapy.
- PRIMARY TREATMENT: SMMART-ACT Tumor Board treatment recommendation of at least one per protocol ACT intervention based on the board's review of SMMART-CAP results on a pre-screening biopsy.
PRIMARY TREATMENT: Absolute neutrophil count (ANC) >= 1,500 / uL (1.5 K/cu mm) (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
- May be waived, per principal investigator (PI), on a case-by-case basis for participant populations recognized to have normal baseline values below this level
- PRIMARY TREATMENT: Platelets >= 100,000 / uL (100 K/cu mm) (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
- PRIMARY TREATMENT: Hemoglobin >= 9 g/dL (or >= 5.6 mmol/L) (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
PRIMARY TREATMENT: Creatinine =< 1.5 x institutional upper limit of normal (IULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 50 mL/min/1.73m^2. (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
- Creatinine clearance should be calculated per institutional standard. For participants with a baseline calculated creatinine clearance below normal institutional laboratory values, a measured baseline creatinine clearance should be determined. Individuals with higher values felt to be consistent with inborn errors of metabolism will be considered on a case-by-case basis.
- PRIMARY TREATMENT: Total bilirubin =< 1.5 x IULN OR direct bilirubin IULN for individuals with total bilirubin levels > 1.5 x IULN. (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
- PRIMARY TREATMENT: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x IULN. (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
- PRIMARY TREATMENT: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x upper limit of normal (ULN) unless individual is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within intended therapeutic range of intended anticoagulant therapy. (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
- PRIMARY TREATMENT: Activated partial thromboplastin time (aPTT) or PTT =< 1.5 x ULN unless participant is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended anticoagulant therapy. (assessed at primary [post pre-screening] screening, or by the time that study intervention commences)
PRIMARY TREATMENT: Body mass index (BMI) >16.0 and < 35.0 kg/m^2
- Participants with a BMI of >= 30.0 will use ideal body weight indices in calculating the delivery of agents that are dosed based upon body surface area (i.e., mg agent/meter squared) or weight (i.e., mg agent/kg body weight)
PRIMARY TREATMENT: Toxicities due to prior therapies should be resolved to baseline or grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] v5.0) before administration of study intervention. The following exceptions are permitted:
- Alopecia, fatigue, and lymphopenia due to prior therapies.
- Toxicities attributed to prior anti-cancer therapy that are not expected to resolve and to result in long lasting sequelae, (e.g., neuropathy after platinum-based therapy), may be permitted.
- PRIMARY TREATMENT: Palliative radiation therapy completed >= two weeks prior to start of SMMART-ACT treatment to a measurable disease lesion (s).
- PRIMARY TREATMENT: Additional eligibility criteria for the intended recommended therapy must also be met.
- PRIMARY TREATMENT: Study intervention-specific eligibility criteria for the intended, recommended therapy must also be met.
CANCER SPECIFIC BREAST CANCER: Lesion(s) remain measurable after systemic therapies, as follows:
- At least one prior line of pharmacological therapy for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative disease.
- At least one prior line of targeted therapy for HER2-postive disease.
- At least one prior line of combination therapy for triple negative disease lacking a BRCA1/2 mutation.
- At least one prior line of therapy with a PARP inhibitor for triple negative disease with a BRCA1/2 mutation.
Exclusion Criteria:
- PRE-SCREENING: Evidence of active malignancy of another cancer with a natural or treatment history that may affect safety or efficacy assessments of this study or impose unacceptable risk to the participant. Guiding examples for those who can be enrolled include: individuals who have been disease free for two years; cancers with high cure rates (e.g., prior history of stage 1 rectal cancer and currently otherwise disease free); adequately treated localized non-melanomatous skin cancer.
- PRE-SCREENING: Involuntarily incarceration, including, but not limited to, imprisonment and compulsory detained for treatment of psychiatric or physical (e.g., infectious disease) illness.
- PRIMARY TREATMENT: Any brain/central nervous system (CNS) metastases or brain/CNS metastases that has progressed (e.g., evidence of new or enlarging brain metastasis that progresses within =< four weeks of CNS directed treatment as ascertained by clinical examination(s) and magnetic resonance imaging (MRI) or computed tomography (CT) during the main eligibility screening period.
- PRIMARY TREATMENT: One or more new, active brain/CNS metastasis or the presence of known leptomeningeal disease (LMD) that requires immediate treatment. If treatment within the first cycle of therapy is unlikely to be required, enrollment may be considered, as per the investigator.
- PRIMARY TREATMENT: Concurrent forms of anti-cancer therapy that have the potential to interfere with efficacy and safety assessments or may that may pose increased risk to the participant while on a SMMART-ACT treatment, and as per the investigator. (Select hormone therapies, are allowed.)
- PRIMARY TREATMENT: Untreated and/or uncured hepatitis C virus (HCV) infection, as evidenced by detectable hepatitis B virus (HBC) ribonucleic acid (RNA) by polymerase chain reaction (PCR). Prior treatment, concurrent treatment, and natural resolution of HCV infection are not exclusionary given (1) no risk for hepatic decompensation and (2) the intended SMMART ACT treatment is not expected to exacerbate HCV infection.
PRIMARY TREATMENT: Uncontrolled intercurrent illness and infection that may interfere with planned treatment including, but not limited to the following:
- Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV)
- Unstable angina pectoris or coronary angioplasty, or stenting within < six months prior to enrollment,
- Cardiac arrhythmia (ongoing cardiac dysrhythmias of grade >=2 [National Cancer Institute (NCI) CTCAE v5.0]),
- Conditions that require intra-cardiac defibrillators,
- Known cardiac metastases,
- History of abnormal cardiac valve morphology (>= grade 2),
- Chronic graft versus host disease (GVHD) or immunosuppressive therapy for the control of GVHD.
- PRIMARY TREATMENT: Severe infection within < four weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
- PRIMARY TREATMENT: Inability or unwillingness to take oral medication (only for assigned oral study interventions).
- PRIMARY TREATMENT: History of allergy to an assigned study agent or its excipients.
- PRIMARY TREATMENT: Current pregnancy, currently breast-feeding, or unwillingness to not breastfeed while receiving study drug(s) or for the minimum required time after the last dose of study drug(s) as specified by the SMMART-ACT drug agents.
- PRIMARY TREATMENT: Any condition that, in the opinion of the investigator, could jeopardize the participant's safety or adherence to the study protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (SMMART-ACT)
Administered in monotherapy or in combination with other targeted agents or immunotherapies, chemotherapies, or radiation.
Combination treatment plans may include a two-week monotherapy lead-in, followed by a combination treatment regimen.
Each ACT study intervention must have an established RP2D determined in a prior clinical trial.
Participants undergo a Pre-Treatment Biopsy, plus an On-Treatment Biopsy after two weeks on first dose of study drug(s) and prior to starting Cycle 2, regardless of regimen.
Participants continue to receive study agent(s) after the On-Treatment Biopsy, according to the biopsy results and the results of ongoing safety and clinical assessments.
Treatment cycles repeat every 21 to 28 days in the absence of disease progression or unacceptable toxicity.
Cycles are determined based on the study agent(s).
Upon disease progression, participants are given the option to undergo an additional biopsy.
|
Given IV
Other Names:
Ancillary studies
Other Names:
Undergo collection of blood
Other Names:
Given IV
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Given IV
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Given IV
Other Names:
Given PO
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Given PO
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Given PO
Other Names:
Given IV
Other Names:
Given IV
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Given PO
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Undergo tissue biopsy
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Given orally (PO)
Other Names:
Given IV
Other Names:
Given by injection
Other Names:
Given phesgo SC
Other Names:
Given subcutaneously (SC)
Other Names:
Given SC
Other Names:
Given intravenously (IV)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants who receive an ACT therapy based an ACT Tumor Board recommendation.
Time Frame: From time of SMMART-ACT Tumor Board review to first dose of SMMART-ACT study drug regime as evaluated at interim analysis (approximately 2 years)
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At interim analysis, if greater than or equal to 11 of the first 15 enrolled participants (80%) receive C1D1 of the recommended ACT drug regimen, the feasibility threshold will be met.
If not attained, reasons as to why the feasibility endpoint was not met will be reviewed.
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From time of SMMART-ACT Tumor Board review to first dose of SMMART-ACT study drug regime as evaluated at interim analysis (approximately 2 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-emergent adverse events
Time Frame: First dose of study drug up to 30 days after last dose study drug(s)
|
Measured by Common Terminology Criteria for Adverse Events version 5.0.
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First dose of study drug up to 30 days after last dose study drug(s)
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Rate of treatment discontinuation due to toxicities and/or intolerability.
Time Frame: First dose of study drug to last dose study drug(s)
|
Measured by Common Terminology Criteria for Adverse Events version 5.0.
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First dose of study drug to last dose study drug(s)
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Overall response rate (ORR)
Time Frame: At 6 months from cycle 1 day 1 +/- 2 weeks (each cycle may be 21 or 28 days, depending on the assigned SMMART ACT regimen)
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Will be assessed by ORR = complete response (CR)+ partial response (PR) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 or in accordance with definition for pseudoprogression indications for immuno monotherapy regimens.
Will be estimated using the Kaplan-Meier method.
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At 6 months from cycle 1 day 1 +/- 2 weeks (each cycle may be 21 or 28 days, depending on the assigned SMMART ACT regimen)
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Progression free survival
Time Frame: From the first dose of study drug until the earliest date of disease progression, as measured by investigator assessment, or death due to any cause (until the end of long-term follow-up (LTFU)), LTFU is up to 5 years
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Will be censored at the date of last adequate assessment visit and will be estimated using the Kaplan Meier method.
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From the first dose of study drug until the earliest date of disease progression, as measured by investigator assessment, or death due to any cause (until the end of long-term follow-up (LTFU)), LTFU is up to 5 years
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Disease-specific survival
Time Frame: Time from the first day of treatment with study intervention to death as a result of the disease at time of last follow-up, LTFU is up to five years from time of last dose of study therapy
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Will be estimated using cumulative incidence methods.
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Time from the first day of treatment with study intervention to death as a result of the disease at time of last follow-up, LTFU is up to five years from time of last dose of study therapy
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Overall survival
Time Frame: From the time of first dose of study drug until death from any cause (until the end of long-term follow-up), LTFU is up to 5 years
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Will be censored on the last date a participant is known to be alive and will summarized descriptively using the Kaplan-Meier method.
The median and 95% confidence interval, will be included in the estimations, if possible.
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From the time of first dose of study drug until death from any cause (until the end of long-term follow-up), LTFU is up to 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lara Davis, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Skin Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Breast Diseases
- Prostatic Diseases
- Pancreatic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Genital Diseases, Female
- Sarcoma
- Breast Neoplasms
- Prostatic Neoplasms
- Carcinoma
- Recurrence
- Ovarian Neoplasms
- Pancreatic Neoplasms
- Carcinoma, Ovarian Epithelial
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Phytogenic
- Topoisomerase Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Poly(ADP-ribose) Polymerase Inhibitors
- Hormone Antagonists
- Immune Checkpoint Inhibitors
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Topoisomerase I Inhibitors
- Immunotoxins
- Carboplatin
- Paclitaxel
- Trastuzumab
- Antibodies
- Olaparib
- Capecitabine
- Immunoglobulins
- Letrozole
- Fulvestrant
- Palbociclib
- Bevacizumab
- Irinotecan
- Albumin-Bound Paclitaxel
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
- Vinorelbine
- Niraparib
- Maytansine
- Trastuzumab biosimilar HLX02
- Anastrozole
- Atezolizumab
- Ado-Trastuzumab Emtansine
- Immunoglobulin G
- Pertuzumab
- Vemurafenib
- Immunoconjugates
- Endothelial Growth Factors
- Entrectinib
- Phosphoinositide-3 Kinase Inhibitors
Other Study ID Numbers
- STUDY00020679 (Other Identifier: OHSU Knight Cancer Institute)
- NCI-2021-12938 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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