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This is a single center, randomized phase II study of an IL-15Rα-Fc super-agonist complex (ALT-803) given as maintenance therapy after the completion of 1st line IV/IP chemotherapy for the treatment of advanced ovarian, fallopian tube, and primary peritoneal cancer.
In this study all patients receive four 8 week cycles of ALT-803 consisting of 4 weekly doses followed by a 4 week rest (no treatment). As it is not known how intraperitoneal (IP) administration (a route of drug administration frequently used for gynecologic cancers) of ALT-803 compares to subcutaneous (SQ) administration, both routes of administration will be tested. The primary objective of this trial is to select one method of delivery for further testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: ALT-803 subcutaneous only | Experimental |
| |
| Arm 2: ALT-803 intraperitoneal and subcutaneous | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALT-803 Subcutaneous | Biological | Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Incidence of Progression Free Survival after first treatment of ALT-803. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Incidence of Progression Free Survival after first treatment of ALT-803.. Survival probability estimate. | 1 year |
| Overall Survival | Overall Survival from start of ALT-803 dosing |
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Inclusion Criteria
Diagnosis of FIGO stage III or grade IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma, has received at least 3 cycles of first line IV/IP cisplatin and paclitaxel chemotherapy and has stable disease or better - refer to Appendix II for FIGO staging system (Note: to be eligible for this study, the patient must receive a minimum of 3 cycles of IP therapy; however, patients may continue on IV only 1st line therapy for additional cycles as long as inclusion criteria 4.1.2 is met)
Able to begin study therapy within 3 months of final dose of first line chemotherapy
Functioning intraperitoneal catheter
≥ 18 years of age
GOG performance status ≤ 2 (Appendix II)
Adequate organ function within 14 days of enrollment defined as:
Ability to be off prednisone and other immunosuppressive drugs for at least 3 days prior to and while receiving ALT-803
Voluntary written consent prior to the performance of any research related procedures
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Geller, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: ALT-803 Subcutaneous Only | ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off) |
| FG001 | Arm 2: ALT-803 Intraperitoneal and Subcutaneous | ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: ALT-803 Subcutaneous Only | ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival | Incidence of Progression Free Survival after first treatment of ALT-803. | survival probability estimate | Posted | Number | 95% Confidence Interval | Percentage of PFS | 6 months |
|
Patients were monitored from first dose of ALT-803 until two years after off treatment date, 3 years in total.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: ALT-803 Subcutaneous Only | ALT-803 Subcutaneous: Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | Systematic Assessment | Grade 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Geller | University of Minnesota, Masonic Cancer Center | +1 612-626-3111 | gelle005@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2019 | Mar 2, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 4, 2021 | Mar 2, 2023 | ICF_001.pdf |
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|
| ALT-803 Intraperitoneal | Biological | Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off). |
|
| 1 year |
| ALT-803 Associated Toxicities | Incidence of ALT-803 associated toxicities after first treatment of ALT-803. | 1 year |
| Incidence of Recorded Toxicity Grade 3 or Greater | Grade 3 adverse events or greater will be measured. A Grade 3 adverse event is defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. | 1 year |
| Progression Free Survival | Incidence of Progression Free Survival after first treatment of ALT-803.. Survival probability estimate. | 2 years |
| Overall Survival | Overall Survival after first treatment of ALT-803. | 2 year |
| BG001 |
| Arm 2: ALT-803 Intraperitoneal and Subcutaneous |
ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Progression Free Survival | Incidence of Progression Free Survival after first treatment of ALT-803.. Survival probability estimate. | survival probability estimate | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 year |
|
|
|
| Secondary | Overall Survival | Overall Survival from start of ALT-803 dosing | survival probability estimate | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 year |
|
|
|
| Secondary | ALT-803 Associated Toxicities | Incidence of ALT-803 associated toxicities after first treatment of ALT-803. | Count of events | Posted | Number | Count of events | 1 year |
|
|
|
| Secondary | Incidence of Recorded Toxicity Grade 3 or Greater | Grade 3 adverse events or greater will be measured. A Grade 3 adverse event is defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. | Count of events | Posted | Number | Number of of adverse events | 1 year |
|
|
|
| Secondary | Progression Free Survival | Incidence of Progression Free Survival after first treatment of ALT-803.. Survival probability estimate. | survival probability estimate | Posted | Number | 95% Confidence Interval | Percentage of PFS | 2 years |
|
|
|
| Secondary | Overall Survival | Overall Survival after first treatment of ALT-803. | Survival probability estimate | Posted | Number | 95% Confidence Interval | Percentage of participants | 2 year |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Arm 2: ALT-803 Intraperitoneal and Subcutaneous | ALT-803 Intraperitoneal: Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off). | 0 | 4 | 0 | 4 | 4 | 4 |
| Chills | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Flu like symptoms | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Gait disturbance | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
|
| General disorders and administration site conditions - Other, specify | General disorders | Systematic Assessment |
|
| Localized edema | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Facial nerve disorder | Nervous system disorders | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythroderma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hirsutism | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vestibular disorder | Ear and labyrinth disorders | Systematic Assessment |
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| Immune system disorders - Other, specify | Immune system disorders | Systematic Assessment |
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| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
|
| Creatinine increased | Investigations | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
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