Malignant MelanomaPhase 1/2NCT02709889

Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors

A Phase 1/2 study testing Rovalpituzumab tesirine and Dexamethasone in people with Malignant Melanoma and Medullary Thyroid Cancer, run by AbbVie at 30 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objective of this study is to assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Malignant Melanoma, Medullary Thyroid Cancer, Glioblastoma
What is being tested?: Rovalpituzumab tesirine and Dexamethasone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 30 sitesUnited States
Study dates: 23 Sep 2016to 27 Aug 2019
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed, unresectable advanced solid malignancy with documented disease progression after at least 1 prior systemic therapy
Disease is relapsed/refractory to prior standard systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Delta-like protein 3 (DLL3)-expressing malignancy based on central immunohistochemical (IHC) testing of representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is defined as staining in ≥ 1% of tumor cells.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Minimum life expectancy of at least 12 weeks

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Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids. Definitive treatment may include surgical resection, whole brain irradiation, and/or stereotactic radiation therapy. (Applicable to tumor types of non-CNS primary origin only)
Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration
Adequate hematologic and organ function as confirmed by laboratory values
Last dose of any prior therapy administered by the following time intervals before the first dose of study drug:
Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.
Immune-checkpoint inhibitors (e.g., anti-programmed death protein 1 [PD-1], anti-programmed death-ligand 1 [PD-L1], or anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4]), monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease progression).
Females of childbearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.

Who cannot join

Any significant medical condition, including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drug.
Recent or ongoing serious infection, including:
Any active grade 3 or higher (per National Cancer Institute Common Terminology Criteria for Adverse Events version [NCI CTCAE] 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted.
Known seropositivity for or active infection by human immunodeficiency virus (HIV).
Active Hepatitis B (by surface antigen expression or polymerase chain reaction) or C (by polymerase chain reaction) infection or on hepatitis-related antiviral therapy within 6 months of first dose of study drug.

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Women who are pregnant or breastfeeding
Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug
History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3year limit include non-melanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma in situ, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on pap smear.
Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation, unless undergoing retreatment with rovalpituzumab tesirine in the context of this protocol

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

University of New Mexico /ID# 205054
Albuquerque, New Mexico, 87102
Emory University Hospital /ID# 155417
Atlanta, Georgia, 30322
Univ of Colorado Cancer Center /ID# 155415
Aurora, Colorado, 80045
Johns Hopkins University /ID# 155412
Baltimore, Maryland, 21287
Massachusetts General Hospital /ID# 155411
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute /ID# 171044
Boston, Massachusetts, 02215
Roswell Park Comprehensive Cancer Center /ID# 162015
Buffalo, New York, 14263
Univ Hosp Cleveland /ID# 155410
Cleveland, Ohio, 44106
Mary Crowley Cancer Research /ID# 162014
Dallas, Texas, 75230
Sarah Cannon Research Institute at HealthONE - Denver /ID# 155420
Denver, Colorado, 80218
Duke University Medical Center /ID# 155421
Durham, North Carolina, 27710-3000
Virginia Cancer Specialists /ID# 162006
Fairfax, Virginia, 22031
Texas Oncology - Forth Worth /ID# 162045
Fort Worth, Texas, 76104-2150
University of Florida - Archer /ID# 155414
Gainesville, Florida, 32610
Banner MD Anderson Cancer Ctr /ID# 155424
Gilbert, Arizona, 85234
Greenville Hospital System /ID# 155427
Greenville, South Carolina, 29605
University of Texas MD Anderson Cancer Center /ID# 155413
Houston, Texas, 77030
University of Kentucky Chandler Medical Center /ID# 155423
Lexington, Kentucky, 40536
University of California, Los Angeles /ID# 155429
Los Angeles, California, 90095
Rutgers Cancer Institute of NJ /ID# 162010
New Brunswick, New Jersey, 08903
Weill Cornell Medical College /ID# 155418
New York, New York, 10021
Oregon Health and Science University /ID# 162011
Portland, Oregon, 97239
Mayo Clinic - Rochester /ID# 155416
Rochester, Minnesota, 55905-0001
University of Utah /ID# 155426
Salt Lake City, Utah, 84112-5500
Univ California, San Francisco /ID# 155409
San Francisco, California, 94143-2204
Mayo Clinic - Scottsdale /ID# 155419
Scottsdale, Arizona, 85259
Washington University-School of Medicine /ID# 155425
St Louis, Missouri, 63110
Moffitt Cancer Center /ID# 170220
Tampa, Florida, 33612-9416
Northwest Cancer Specialists, P.C. /ID# 155431
Vancouver, Washington, 98684
Cedars-Sinai Medical Center - West Hollywood /ID# 155428
West Hollywood, California, 90048

Other trials in United States

About this study

Official title: An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors

The primary objective of this study is to assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.

Read the detailed description

This is a multicenter, open-label study involving multiple specific advanced solid tumor types, consisting of a dose escalation part A followed by an expansion part B. Cancer subtypes will be studied in separate disease-specific cohorts in both Parts. Eight separate cohorts will enroll malignant melanoma, medullary thyroid cancer (MTC), glioblastoma, large cell neuroendocrine carcinoma (LCNEC), neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic neuroendocrine carcinoma (GEP NEC), other NEC, and solid tumors other than the above.

Conditions: Malignant Melanoma, Medullary Thyroid Cancer, Glioblastoma, Large-Cell Neuroendocrine Carcinoma, Neuroendocrine Prostate Cancer, High Grade Gastroenteropancreatic Neuroendocrine Carcinoma
Being tested: Rovalpituzumab tesirine, Dexamethasone
Medical subject headings: Melanoma, Carcinoma, Medullary, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rovalpituzumab tesirineDrug
Also called SC16LD6.5
DexamethasoneDrug
Dexamethasone will be provided through a participant's local prescription by Investigator or other provider (i.e., dexamethasone will not be provided by the Sponsor).

Study groups in NCT02709889
Study group	Role	What they receive
Rovalpituzumab Tesirine	Experimental	Rovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle. Receives: Drug: Rovalpituzumab tesirine; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups
The number of participants with TEAEs, serious TEAEs, study drug-related TEAEs, and study drug discontinuations or dose reductions due to TEAEs, summarized by dose received and neuroendocrine (NEC) or non-NEC disease groups. An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: is fatal or life-threatening; results in death or hospitalization; is disabling/incapacitating or a congenital anomaly/birth defect; is medically significant. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03 terminology: grade 1=mild; grade 2=moderate; grade 3=severe; grade 4 life-threatening; grade 5=death. TEAEs were defined as AEs that were newly occurring or worsened following study treatment.
Measured: From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).

Secondary outcomes (7)

Objective Response Rate (ORR)
ORR is defined as percentage of participants whose best overall response was either complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with best overall response (confirmed or unconfirmed) of CR, PR or stable disease (SD) per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressed disease (PD), taking as reference the smallest sum diameters while on study. SD criteria must have met at least once after study entry at a minimum interval of 42 days (-7 days to allow for scheduled visit window per the protocol).
Measured: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Duration of Response (DOR)
DOR is defined as the time from the first assessment on therapy of a CR or PR response (per RECIST v1.1) to the date of progressive disease or death. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have progression were censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates.
Measured: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Progression Free Survival (PFS)
PFS is defined as the time from the first dose date to the date of disease progression or death. Participants who did not have progression or death are censored at the last non-missing response assessment on-therapy or baseline. Based on Kaplan-Meier estimates.
Measured: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Overall Survival (OS)
Overall survival is defined as the time from the first dose date to death for any reason. Subjects who were alive at the clinical data cut-off are censored at the last known alive date. Based on Kaplan-Meier estimates.
Measured: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Serum Concentrations of Rovalpituzumab Tesirine Over Time
Measured: Cycle 1: 0, 0.5, 6, 48, 168, 336, 672 hours postdose
Number of Participants With Anti-therapeutic Antibodies (ATA)
Number of participants treated across each dose level reported to potentially have ATAs against rovalpituzumab tesirine at any time during the study.
Measured: Day 1 and 42 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 201627 Aug 2019

First posted16 Mar 2016 (estimated)
Study start23 Sep 2016
Primary completion27 Aug 2019
Study completion27 Aug 2019

Why it stopped: Strategic considerations

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Malignant MelanomaStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02709889
Sponsor's protocol ID: SCRX001-006
Status last verified: Sep 2020
First submitted: 2 Mar 2016
Last updated: 19 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

Xie H, Kaye FJ, Isse K, Sun Y, Ramoth J, French DM, Flotte TJ, Luo Y, Saunders LR, Mansfield AS. Delta-Like Protein 3 Expression and Targeting in Merkel Cell Carcinoma. Oncologist. 2020 Sep;25(9):810-817. doi: 10.1634/theoncologist.2019-0877. Epub 2020 May 14.
PubMed 32372416

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malignant Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors
ClinicalTrials.gov ID: NCT02709889
Acronym / sponsor ID: SCRX001-006
Conditions: Malignant Melanoma, Medullary Thyroid Cancer, Glioblastoma, Large-Cell Neuroendocrine Carcinoma, Neuroendocrine Prostate Cancer, High Grade Gastroenteropancreatic Neuroendocrine Carcinoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Strategic considerations
Enrolment: 200 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 23 Sep 2016 (actual)
Primary completion: 27 Aug 2019 (actual)
Study completion: 27 Aug 2019 (actual)
First posted: 16 Mar 2016 (estimated)
Results: Posted 19 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study is to assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rovalpituzumab Tesirine	Experimental	Drug: Rovalpituzumab tesirine, Drug: DexamethasoneRovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Histologically confirmed, unresectable advanced solid malignancy with documented disease progression after at least 1 prior systemic therapy
Disease is relapsed/refractory to prior standard systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Delta-like protein 3 (DLL3)-expressing malignancy based on central immunohistochemical (IHC) testing of representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is defined as staining in ≥ 1% of tumor cells.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key exclusion criteria (10 listed)

Any significant medical condition, including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drug.
Recent or ongoing serious infection, including:
Women who are pregnant or breastfeeding
Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rovalpituzumab tesirineAlso: SC16LD6.5	Drug	Rovalpituzumab Tesirine
DexamethasoneDexamethasone will be provided through a participant's local prescription by Investigator or other provider (i.e., dexamethasone will not be provided by the Sponsor).	Drug	Rovalpituzumab Tesirine

Primary outcome

Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups
Time frame: From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).
The number of participants with TEAEs, serious TEAEs, study drug-related TEAEs, and study drug discontinuations or dose reductions due to TEAEs, summarized by dose received and neuroendocrine (NEC) or non-NEC disease groups. An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: is fatal or life-threatening; results in death or hospitalization; is disabling/incapacitating or a congenital anomaly/birth defect; is medically significant. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03 terminology: grade 1=mild; grade 2=moderate; grade 3=severe; grade 4 life-threatening; grade 5=death. TEAEs were defined as AEs that were newly occurring or worsened following study treatment.

7 secondary outcomes

Objective Response Rate (ORR)
Time frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Clinical Benefit Rate (CBR)
Time frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Duration of Response (DOR)
Time frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Progression Free Survival (PFS)
Time frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Overall Survival (OS)
Time frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Serum Concentrations of Rovalpituzumab Tesirine Over Time
Time frame: Cycle 1: 0, 0.5, 6, 48, 168, 336, 672 hours postdose
Number of Participants With Anti-therapeutic Antibodies (ATA)
Time frame: Day 1 and 42 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).

Results and safety

Results posted to the registry on 19 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Rovalpituzumab Tesirine 0.2 mg/kg	43	0
Part A: Rovalpituzumab Tesirine 0.3 mg/kg	57	0
Part A: Rovalpituzumab Tesirine 0.4 mg/kg	12	0
Part B: Rovalpituzumab Tesirine 0.3 mg/kg	88	0

Primary outcome: Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups

Time frame: From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).. Number. Unit: participants

Measure	NEC: 0.2 mg/kg n = 24	NEC: 0.3 mg/kg n = 69	NEC: 0.4 mg/kg n = 8	NEC: Any Dose n = 101	Non-NEC: 0.2 mg/kg n = 19	Non-NEC: 0.3 mg/kg n = 76	Non-NEC: 0.4 mg/kg n = 4	Non-NEC: Any Dose n = 99
≥ 1 TEAE	24	69	8	101	18	75	4	97
≥ 1 TEAE, Grade 3-4	20	40	5	65	10	38	4	52
≥ 1 TEAE, Grade 5	1	13	2	16	3	8	0	11
≥ 1 Serious TEAE	16	39	5	60	10	38	3	51
≥ 1 Serious TEAE, Grade 3-4	16	24	3	43	6	25	3	34
≥ 1 Serious TEAE, Grade 5	0	13	2	15	3	8	0	11
≥ 1 Drug-Related (DR) Serious TEAE	6	20	3	29	3	14	3	20
≥ 1 DR Serious TEAE, Grade 3-4	6	15	1	22	3	8	3	14

Population analysed: Safety Analysis Set: participants who received any amount of study drug. Presented by NEC/Non-NEC groups, inclusive of participants in parts A and B.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.2_mg_kg_(LCNEC)	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
0.2_mg_kg_(NEPC)	3 of 4 (75%)	4 of 4 (100%)	3 of 4
0.2_mg_kg_(GEPNEC)	2 of 6 (33.3%)	6 of 6 (100%)	5 of 6
0.2_mg_kg_(Other_NEC)	9 of 11 (81.8%)	11 of 11 (100%)	9 of 11
0.2_mg_kg_(MM)	2 of 3 (66.7%)	3 of 3 (100%)	3 of 3
0.2_mg_kg_(MTC)	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
0.2_mg_kg_(GBM)	2 of 4 (50%)	4 of 4 (100%)	4 of 4
0.2_mg_kg_(Other_Solid)	5 of 9 (55.6%)	8 of 9 (88.9%)	6 of 9
0.3_mg_kg_(LCNEC)	6 of 8 (75%)	8 of 8 (100%)	6 of 8
0.3_mg_kg_(NEPC)	8 of 14 (57.1%)	14 of 14 (100%)	11 of 14
0.3_mg_kg_(GEPNEC)	15 of 28 (53.6%)	27 of 28 (96.4%)	16 of 28
0.3_mg_kg_(Other_NEC)	10 of 19 (52.6%)	19 of 19 (100%)	12 of 19
0.3_mg_kg_(MM)	8 of 17 (47.1%)	16 of 17 (94.1%)	10 of 17
0.3_mg_kg_(MTC)	3 of 10 (30%)	10 of 10 (100%)	3 of 10
0.3_mg_kg_(GBM)	8 of 18 (44.4%)	18 of 18 (100%)	13 of 18
0.3_mg_kg_(Other_Solid)	19 of 31 (61.3%)	31 of 31 (100%)	25 of 31
0.4_mg_kg_(GBM)	0 of 1 (0%)	1 of 1 (100%)	0 of 1
0.4_mg_kg_(GEPNEC)	2 of 2 (100%)	2 of 2 (100%)	2 of 2
0.4_mg_kg_(LCNEC)	1 of 2 (50%)	2 of 2 (100%)	0 of 2
0.4_mg_kg_(NEPC)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32372416Xie H, Kaye FJ, Isse K, Sun Y, Ramoth J, French DM, Flotte TJ, Luo Y, Saunders LR, Mansfield AS. Delta-Like Protein 3 Expression and Targeting in Merkel Cell Carcinoma. Oncologist. 2020 Sep;25(9):810-817. doi: 10.1634/theoncologist.2019-0877. Epub 2020 May 14.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AbbVie Inc. study director

AbbVie

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rovalpituzumab tesirine and Dexamethasone in people with Malignant Melanoma and Medullary Thyroid Cancer, run by AbbVie at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups (time frame: From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02709889, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.