A Phase 1 interventional study of (Arginaid®) Oral Arginine and (R-Gene® 10) IV Arginine in Platinum Resistant Ovarian Cancer, Fallopian Tube Cancers and Peritoneal Carcinoma, sponsored by Rebecca Arend. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Rebecca Arend · Phase 1, Interventional, and Treatment
Among 589 studies in Fallopian Tube Neoplasms with a site in United States — 63 open to participants now, 130 under way, 24 of them phase 3. Fallopian Tube Neoplasms · United States.
Among the 589 studies in Fallopian Tube Neoplasms with a site in United States, this one is the 345th largest by planned enrollment of the 513 interventional ones that give a count, is one of 7 that started in 2026, is one of 181 in phase 1, reaches primary completion later than 104 of the 129 other live ones, and was the 585th registered.
835 studies on the registry are indexed under Fallopian Tube Neoplasms; 131 are open to participants now.
Browse Fallopian Tube Neoplasms studies →63 of the 589 studies in Fallopian Tube Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in United States, Israel, Taiwan
Ages 18+ · Women only
AstraZeneca · Sites in United States, Australia, Brazil and 10 more countries
Ages 18+ · Women only
Merck Sharp & Dohme LLC · Sites in United States, Israel, Korea, Republic of and 2 more countries
Ages 18+ · Women only
University of Washington · Sites in United States
Ages 18+ · Women only
AstraZeneca · Sites in United States, Argentina, Australia and 26 more countries
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 105 Fallopian Tube Neoplasms studies recruiting now, 87 (83%) set no upper age limit and 10 (10%) stop at 75 or younger; 6 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 89 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
589 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 239 · Phase 2 275 · Phase 3 60
First in 1992; this study’s year is marked. 7 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 50 across 684 interventional studies indexed under Fallopian Tube Neoplasms.
Median enrollment 40 across the 513 interventional studies, 119 across the 45 observational. Of the 420 that completed or were terminated, 202 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
170 of 589 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Rebecca Arend as lead sponsor.
Rebecca Arend has 1 study filed under Fallopian Tube Neoplasms — fewer than ten, so there is no comparison to draw.
39 of the studies in Fallopian Tube Neoplasms with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05281471Phase 3Genelux CorporationEfficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076) | 2026-12 |
| NCT04498117Phase 3CanariaBio Inc.Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery | 2026-12-26 |
| NCT04095364Phase 3NRG OncologyLetrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | 2027-02-01 |
| NCT05445778Phase 3AbbVieMirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer | 2027-04 |
| NCT05456685AbbVieMirvetuximab Soravtansine (MIRV) With Carboplatin in Second-line Treatment of Folate Receptor Alpha (FRα) Expressing, Platinum-sensitive Epithelial Ovarian Cancer | 2026-11 |
Add all 39 to your calendar (.ics) → With an account.
Among the 589 studies in Fallopian Tube Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is an open-label, Phase 1 clinical study to evaluate the safety, tolerability, PK profiles, and clinical activity of IV and PO arginine supplementation + SOC chemoimmunotherapy regimens in participants with PROC.
This is a Phase I, investigator-initiated and open-label study. Patients will be evaluated and treated at University of Alabama Birmingham Hospital. Patients will receive both oral and IV arginine with the physician choice of paclitaxel, pembrolizumab, +/- bevacizumab or pembrolizumab, bevacizumab, and oral cyclophosphamide, where doses and schedule are consistent with standard of care. Patients who are excluded from the trial due to progression will be scheduled for three- and six-months follow-up evaluations after the last dose. The goal for enrollment will be 6-24 patients with a 3-patient safety dose escalation lead-in using a 3+3 enrollment model for each regimen.
Patients meeting eligibility criteria will be approached and both verbal and written consent will be obtained prior to treatment. Patients on trial will receive the IV R-Gene 10 (30g) IV arginine, every 3 weeks (q3w) plus PO Arginaid 4.5g PO daily with one of two systemic standard of care treatment regimens: Standard of care treatment #1 is 50mg of daily oral cyclophosphamide, intravenous pembrolizumab 200 mg q3w, and bevacizumab, 15 mg/kg, q3w; standard of care treatment #2 is weekly paclitaxel 80mg/m2 and 200mg of IV pembrolizumab q3wks +/- bevacizumab, 15 mg/kg, q3w in patients with CPS >1.
(CPS) Combined Positive Score (PD-L1)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient must be a candidate for either cohort A or cohort B treatment backbone.
Patients must have adequate hematologic, liver and kidney functions prior to lead-in chemotherapy defined as:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort A: Cohort A1\_Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + 4.5g daily oral arginine (Arginaid®) Cohort A2\_Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine (R-Gene® 10) Cohort A3\_Weekly paclitaxel + q3w pembrolizumab +/- bevacizumab + q3w 30g IV arginine + 4.5g daily PO arginine (Arginaid®) A3 Expansion\_Continue previous regimen OR Cohort B: Cohort B1\_q3w IV bevacizumab, q3w IV pembrolizumab, daily oral phosphamide, 4.5g daily oral arginine (Arginaid®) Cohort B2\_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine (R-Gene® 10) Cohort B3\_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine (R-Gene® 10) + 4.5g PO arginine (Arginaid®) B3 Expansion\_ Continue previous regimen
Drug: (Arginaid®) Oral Arginine · Drug: (R-Gene® 10) IV Arginine · Drug: Pembrolizumab · Drug: Bevacizumab · Drug: Paclitaxel · Drug: oral phosphamide
Cohort B: Cohort B1\_q3w IV bevacizumab, q3w IV pembrolizumab, daily oral phosphamide, 4.5g daily oral arginine (Arginaid®) Cohort B2\_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine (R-Gene® 10) Cohort B3\_q3w IV bevacizumab + q3w IV pembrolizumab + daily oral phosphamide + 30mg IV arginine (R-Gene® 10) + 4.5g PO arginine (Arginaid®) B3 Expansion\_ Continue previous regimen
Drug: (Arginaid®) Oral Arginine · Drug: (R-Gene® 10) IV Arginine · Drug: Pembrolizumab · Drug: Bevacizumab · Drug: oral phosphamide
Patients will receive one of two SOC options of chemotherapy and immunotherapy with the addition of IV and PO supplemental arginine. Regimen 1 will be pembrolizumab, bevacizumab, and oral cyclophosphamide and regimen 2 will be paclitaxel and pembrolizumab +/- bevacizumab with doses and schedule consistent with standard of care.
Also known as: Oral Arginine
Patients will receive one of two SOC options of chemotherapy and immunotherapy with the addition of IV and PO supplemental arginine. Regimen 1 will be pembrolizumab, bevacizumab, and oral cyclophosphamide and regimen 2 will be paclitaxel and pembrolizumab +/- bevacizumab with doses and schedule consistent with standard of care.
Also known as: IV Arginine
Patients will receive one of two SOC options of chemotherapy and immunotherapy with the addition of IV and PO supplemental arginine. Regimen 1 will be pembrolizumab, bevacizumab, and oral cyclophosphamide and regimen 2 will be paclitaxel and pembrolizumab +/- bevacizumab with doses and schedule consistent with standard of care.
Also known as: Keytruda
Patients will receive one of two SOC options of chemotherapy and immunotherapy with the addition of IV and PO supplemental arginine. Regimen 1 will be pembrolizumab, bevacizumab, and oral cyclophosphamide and regimen 2 will be paclitaxel and pembrolizumab +/- bevacizumab with doses and schedule consistent with standard of care.
Also known as: AVASTIN®
Patients will receive one of two SOC options of chemotherapy and immunotherapy with the addition of IV and PO supplemental arginine. Regimen 1 will be pembrolizumab, bevacizumab, and oral cyclophosphamide and regimen 2 will be paclitaxel and pembrolizumab +/- bevacizumab with doses and schedule consistent with standard of care.
Also known as: Taxol
Patients will receive one of two SOC options of chemotherapy and immunotherapy with the addition of IV and PO supplemental arginine. Regimen 1 will be pembrolizumab, bevacizumab, and oral cyclophosphamide and regimen 2 will be paclitaxel and pembrolizumab +/- bevacizumab with doses and schedule consistent with standard of care.
Also known as: cyclophosphamide
Proportion of patients with serious adverse events
This measures the proportion of patients experiencing serious adverse events
Time frame: Baseline through year 2
Overall Response Rate
Tumor burden will be evaluated in all participants by the investigator at screening and during/after the intervention period per RECIST 1.1 guidelines. Based on changes in tumor burden, participants will be classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). Participants who are classified as CR or PR will be defined as responders. The overall response rate (ORR) is the proportion of responders out of the evaluable participants. ORR = (PR + CR)/(PR + CR+ SD+ PD)
Time frame: Baseline through year 2
Duration of Response
Duration of response (DOR) is a time-to-event endpoint measured only in participants who respond to treatment. DOR is the time between response to treatment and disease progression or death. Patients who are lost to follow-up before disease progression or death are censored at time of last contact.
Time frame: Baseline through year 2
Disease control rate
Tumor burden will be evaluated in all participants by the investigator at screening and during/after the intervention period per RECIST 1.1 guidelines. Based on changes in tumor burden, participants will be classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). Participants who are classified as CR, PR or SD will be defined as having disease control. The disease control rate (DCR) is the proportion of participants with disease control out of the evaluable participants. DCR = (PR + CR + SD)/(PR + CR+ SD+ PD)
Time frame: Baseline through year 2
Progression Free Survival
Progression free survival (PFS) is a time-to-event endpoint. PFS is the time between start of treatment and the earlier of disease progression or death. Patients who are lost to follow-up before disease progression or death are censored at time of last contact.
Time frame: Baseline through year 2
Overall Survival
Overall survival (OS) is a time-to-event endpoint. OS is the time between start of treatment and death. Patients who are lost to follow-up before death are censored at time of last contact.
Time frame: Baseline through year 2
Start is estimated for Sep 2026; primary completion for Oct 2028, 25 months later.
Of 65 non-industry phase 1 interventional studies under Fallopian Tube Neoplasms, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 87. This study's planned 25 months is below that.
Counting every sponsor, half of 96 studies reached it within 54 months; a quarter within 36 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Arginine