Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV

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Brief Title

Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV

Official Title

Pilot Trial of Nivolumab Plus Cabozantinib for Advanced Solid Tumors in Patients With HIV Infection

Brief Summary

      This phase I trial investigates the side effects of cabozantinib and nivolumab in treating
      patients with cancer that has spread to other places in the body (advanced) and who are
      undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib may stop the growth
      of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with
      monoclonal antibodies, such as nivolumab, may help the body's immune system attack the
      cancer, and may interfere with the ability of tumor cells to grow and spread. Giving
      cabozantinib and nivolumab may shrink or stabilize cancer in patients undergoing treatment
      for HIV.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the safety of combined nivolumab and cabozantinib s-malate (XL184
      [cabozantinib]) in human immunodeficiency virus (HIV) patients with advanced solid tumors.

      II. To determine the feasibility to deliver the combined nivolumab and XL184 (cabozantinib)
      for a minimum of 4 cycles in at least 75% of the subjects in the expanded cohort with Kaposi
      sarcoma (KS) or to achieve a confirmed objective response.

      SECONDARY OBJECTIVES:

      I. To observe and record anti-tumor activity in subjects with Kaposi Sarcoma (KS).

      II. To assess the effect of treatment on participants' immune status (CD4 and CD8 cell
      counts) and HIV viral loads.

      III. To preliminarily evaluate the objective response rate (ORR) to the combination treatment
      in subjects with KS.

      EXPLORATORY OBJECTIVES:

      I. To assess duration of response (DOR), progression-free survival (PFS), and overall
      survival (OS) in subjects with KS.

      II. To assess the PD-L1 immunohistochemistry (IHC) status in tumors and tumor
      microenvironment and its association with clinical outcome.

      III. To assess the expression characteristics and cellular distribution of immune checkpoints
      (PD-L1, B7x, HHLA2, B7H3), infiltrating immune cells (CD4 T cells, CD8 T cells, regulatory
      T-cells [Tregs], myeloid-derived suppressor cell [MDSC]), and other tumor microenvironment
      biomarkers (VEGF, VEGFR, MET, and AXL) in the tissue by multiplex quantitative
      immunofluorescence (MQIF).

      IV. To correlate markers of immune activation and expansion of immune cell subsets and
      cytokines with clinical outcomes.

      V. To assess the treatment effects on latent HIV reservoir. VI. To investigate the dynamic
      changes of immune checkpoints, angiogenesis markers, and infiltrating immune cells among
      subjects with available pre- and post-treatment biopsy samples (including subjects with
      Kaposi sarcoma [KS]).

      OUTLINE:

      Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28 and nivolumab
      intravenously (IV) over 30 minutes on day 1. Cycles repeat every 28 days for up to 1 year or
      1 year after a partial response is achieved, or 6 months after a complete response is
      achieved in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 16 weeks.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence of dose limiting toxicities (DLTs)

Secondary Outcome

 Immune status

Condition

Advanced Differentiated Thyroid Gland Carcinoma

Intervention

Cabozantinib S-malate

Study Arms / Comparison Groups

 Treatment (cabozantinib s-malate, nivolumab)
Description:  Patients receive cabozantinib s-malate PO QD on days 1-28 and nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

18

Start Date

November 4, 2020

Completion Date

November 2, 2025

Primary Completion Date

November 2, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  For the six-patient safety cohort, subjects must have histologically or cytologically
             confirmed advanced solid tumors that are metastatic or recurrent, and require
             palliative systemic treatment, for which there are either Food and Drug Administration
             (FDA) approved indications for XL184 (cabozantinib) or nivolumab or have at least
             phase 2 data clearly indicating activity (such as renal cell carcinoma [RCC],
             hepatocellular carcinoma [HCC], medullary thyroid carcinoma [MTC], melanoma, non-small
             cell lung cancer [NSCLC], head and neck cancer, urothelial carcinoma, small cell lung
             cancer [SCLC], radioiodine-refractory differentiated thyroid cancer, ovarian cancer,
             castration-resistant prostate carcinoma [CRPC], and triple-negative breast cancer
             [TNBC]). Subjects must have progressed, or are intolerant, or decline systemic therapy
             associated with clinically significant survival benefit if checkpoint blockade is not
             an approved or accepted treatment. The expansion cohort is limited to subjects with
             KS. Histologic, cytologic, and pathologic confirmation of KS is required

          -  Any number of prior cancer therapies will be permitted, including treatment naive
             subjects. (Note: For KS, treatment naive asymptomatic subjects will be permitted. But
             treatment naive KS subjects with visceral symptomatic disease or complicated KS HHV 8
             disease including Castleman's disease will be excluded and should receive front-line
             standard of care)

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky >= 80%)

          -  Subjects with tumors other than KS must have evaluable disease

          -  Absolute neutrophil count >= 1,000/mcL

          -  Platelets >= 75,000/mcL

          -  Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (If, however, the
             participant has Gilbert's disease or unconjugated hyperbilirubinemia that is
             considered to be secondary to antiretroviral therapy, then the total bilirubin must be
             =< 3 x ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 3 x institutional ULN

          -  Creatinine =< 1.5 institutional ULN OR creatinine clearance (CrCl) >= 50 mL/min (if
             using the Cockcroft-Gault formula)

          -  Hemoglobin >= 9 g/dL

          -  Serum albumin >= 2.8 g/dL

          -  Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis

          -  Urine protein/creatinine ratio (UPCR) =< 1

          -  CD4 count >= 50/mcL

          -  Subjects must have known HIV infection as below: Serologic documentation of HIV
             infection at any time prior to study entry, as evidenced by positive enzyme-linked
             immunosorbent assay (ELISA), positive Western blot, or any other federally approved
             licensed HIV test. Alternatively, this documentation may include a record that another
             physician has documented that the participant has HIV infection based on prior ELISA
             and Western blot, or other approved diagnostic tests. Subjects must receive
             appropriate care and treatment for HIV infection. An eligible patient should be on
             anti-retroviral therapy (ART) that is not strongly CYP3A4 inhibiting or otherwise
             prohibited by the protocol (e.g. drug-drug interactions) or the patient must be
             converted to one of these regimens before starting investigational therapy in order to
             avoid dose modulation of cabozantinib

          -  Life expectancy of >= 12 weeks

          -  For subjects with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
             load must be undetectable on suppressive therapy, if indicated

          -  Subjects with a history of hepatitis C virus (HCV) infection must have been treated
             and cured. For subjects with HCV infection who are currently on treatment, they are
             eligible if they have an undetectable HCV viral load

          -  Subjects with a prior or concurrent malignancy whose natural history or treatment does
             not have the potential to interfere with the safety or efficacy assessment of the
             investigational regimen are eligible for this trial

          -  The effects of nivolumab and XL184 (cabozantinib) on the developing human fetus are
             unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree
             to use adequate contraception (hormonal or barrier method of birth control;
             abstinence) prior to study entry and for the duration of study participation. WOCBP
             should use an adequate method to avoid pregnancy for 5 months after the last dose of
             investigational drug. WOCBP must have a negative serum or urine pregnancy test within
             72 hours prior to the start of receiving the first dose of the study medication. Men
             who are sexually active with WOCBP must use any contraceptive method with a failure
             rate of less than 1% per year. Men receiving nivolumab and who are sexually active
             with WOCBP will be instructed to adhere to contraception for a period of 7 months
             after the last dose of investigational product. Women who are not of childbearing
             potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic
             men) do not require contraception

               -  Women of childbearing potential (WOCBP) is defined as any female who has
                  experienced menarche and who has not undergone surgical sterilization
                  (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause
                  is defined clinically as 12 months of amenorrhea in a woman over 45 in the
                  absence of other biological or physiological causes. In addition, women under the
                  age of 55 must have a documented serum follicle stimulating hormone (FSH) level
                  less than 40 mIU/mL

          -  Ability to understand and the willingness to sign a written informed consent document.
             Subjects with impaired decision-making capacity (IDMC) who have a legally-authorized
             representative (LAR) and/or family member available will also be eligible

        Exclusion Criteria:

          -  For the safety run-in cohort, subjects who have received prior XL184 (cabozantinib),
             PD-1/PD-L1 inhibitor, or VEGFR inhibitor are ineligible. Prior treatment with these
             agents is allowed for the expansion KS cohort

          -  Subjects on potent CYP3A4-inhibiting agents are ineligible, such as:

               -  Antiretroviral: ritonavir, cobicistat, indinavir, atazanavir, delavirdine

               -  Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin

               -  Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole, posaconazole

               -  Antidepressants: nefazodone

               -  Antidiuretic: conivaptan

               -  Gastrointestinal (GI): cimetidine, aprepitant

               -  Hepatitis C: boceprevir, telaprevir

               -  Miscellaneous: Seville oranges, grapefruit, or grapefruit juice and/or pummelos,
                  star fruit, exotic citrus fruits, or grapefruit hybrids Of note, to meet the
                  eligibility requirement, subjects are allowed to convert their antiretroviral
                  medications to one of the regimens not including potent CYP3A4-inhibiting agents,
                  when the subjects have progressed, are intolerant, or decline the standard
                  systemic therapy for their advanced tumors.

        Subjects must receive appropriate care and treatment for HIV infection, including
        antiretroviral medications, when clinically indicated (including no ART) and should be
        under the care of a physician experienced in HIV management. Subjects will be eligible
        provided there is no intention to initiate therapy or the regimen has been stable for at
        least 4 weeks with no intention to change the regimen within 8 weeks following study entry.

        To enroll in the study, the participants should be on the protocol accepted ART as long as
        they are receiving XL184 (cabozantinib)

          -  Subjects who have had cytotoxic chemotherapy (including investigational cytotoxic
             chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 3 weeks, or
             nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment, or
             those who have not recovered from adverse events (AEs) due to agents administered more
             than 4 weeks earlier

          -  The subject has received radiation therapy:

               -  To the thoracic cavity, abdomen, or pelvis within 4 weeks before the first dose
                  of study treatment, or has ongoing complications, or is without complete recovery
                  and healing from prior radiation therapy

               -  To bone or brain metastases within 14 days before the first dose of study
                  treatment

               -  To any other site(s) within 21 days before the first dose of study treatment

          -  Subjects who are receiving any other investigational agents

          -  Subjects must be either off corticosteroids, or on a stable or decreasing dose of =<
             10 mg daily prednisone (or equivalent) for at least 2 weeks prior to enrollment.
             Inhaled or topical steroids are permitted in the absence of active autoimmune disease

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to nivolumab or XL184 (cabozantinib)

          -  The subject has prothrombin time (PT)/ international normalized ratio (INR) or partial
             thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the
             first dose of study treatment

          -  The subject has a primary brain tumor, active brain metastases or epidural disease.
             Subjects with brain metastases previously treated with whole brain radiation or
             radiosurgery or participants with epidural disease previously treated with radiation
             or surgery who are asymptomatic and do not require steroid treatment for at least 2
             weeks before starting study treatment are eligible. Subjects with treated brain
             metastasis should not take enzyme-inducing anticonvulsive therapies (EIACDs) within 2
             weeks of registration, though non-enzyme inducing anticonvulsive drugs such as
             levetiracetam are allowed. Neurosurgical resection of brain metastases or brain biopsy
             is permitted if completed at least 3 months before starting study treatment. Baseline
             brain imaging with contrast-enhanced computed tomography (CT) or magnetic resonance
             imaging (MRI) scans for participants with known brain metastases is required to
             confirm eligibility. Subjects with untreated central nervous system (CNS) metastases
             are eligible if they are not symptomatic and the lesions are less than 1 cm in size.
             CNS metastases should be stable for at least 4 weeks, neurologically asymptomatic and
             without corticosteroid treatment at time of first dose of study treatment

          -  Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin
             inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet
             inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:

               -  Prophylactic use of low-dose aspirin for cardio-protection (per local applicable
                  guidelines) and low-dose low molecular weight heparins (LMWH)

               -  Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors
                  rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who
                  are on a stable dose of the anticoagulant for at least 1 week before first dose
                  of study treatment without clinically significant hemorrhagic complications from
                  the anticoagulation regimen or the tumor

          -  The subject has experienced any of the following:

               -  Clinically-significant gastrointestinal bleeding within 6 months before the first
                  dose of study treatment

               -  Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months before the
                  first dose of study treatment

               -  Any other signs indicative of pulmonary hemorrhage within 3 months before the
                  first dose of study treatment

          -  The subject has radiographic evidence of cavitating pulmonary lesion(s)

          -  The subject has tumor in contact with, invading, or encasing any major blood vessels

          -  The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or
             large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor
             within 28 days before the first treatment

          -  The subject has uncontrolled and significant cardiovascular disorders:

               -  Congestive heart failure (CHF): New York Heart Association (NYHA) class III
                  (moderate) or class IV (severe) at the time of screening

               -  Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) >
                  140 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive
                  treatment within 7 days of the first dose of study treatment

               -  The subject has a corrected QT interval calculated by the Fridericia formula
                  (QTcF) > 500 ms within 28 days before treatment

                    -  Note: If initial QTcF is found to be > 500 ms, two additional
                       electrocardiograms (EKGs) separated by at least 3 minutes should be
                       performed. If the average of these three consecutive results for QTcF is =<
                       500 ms, the subject meets eligibility in this regard

               -  Any of the following within 6 months before the first dose of study treatment:

                    -  Unstable angina pectoris

                    -  Clinically-significant cardiac arrhythmias

                    -  Stroke

                    -  Myocardial infarction

                    -  Subjects with a venous filter (e.g. vena cava filter) are not eligible

                    -  Thromboembolic event

          -  The subject has uncontrolled and significant disorders particularly those associated
             with a high risk of perforation or fistula formation including:

               -  Any of the following within 28 days before the first dose of study treatment:

                    -  Active and symptomatic peptic ulcer disease

                    -  Evidence of active or acute diverticulitis, intra-abdominal abscess, GI
                       obstruction and abdominal carcinomatosis which are known risk factors for
                       bowel perforation should be evaluated for the potential need for additional
                       treatment before coming on study

               -  Any of following within 6 months before the first dose of study treatment:

                    -  Abdominal fistula

                    -  Gastrointestinal perforation

                    -  Bowel obstruction or gastric outlet obstruction intra-abdominal abscess.
                       Note: Complete resolution of an intra-abdominal abscess must be confirmed
                       prior to initiating treatment with cabozantinib even if the abscess occurred
                       more than 6 months before

               -  Other disorders associated with a high risk of fistula formation including
                  percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months before
                  the first dose of study therapy

          -  Subjects with active autoimmune disease or history of autoimmune disease that might
             recur, which may affect vital organ function or require immune suppressive treatment
             including systemic corticosteroids, should be excluded. These include but are not
             limited to subjects with a history of immune related neurologic disease, multiple
             sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia
             gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE),
             connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's,
             ulcerative colitis, hepatitis; and subjects with a history of toxic epidermal
             necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be
             excluded because of the risk of recurrence or exacerbation of disease. Subjects with
             vitiligo, endocrine deficiencies including thyroiditis managed with replacement
             hormones including physiologic corticosteroids are eligible. Subjects with rheumat
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Haiying Cheng, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04514484

Organization ID

NCI-2020-05956

Secondary IDs

NCI-2020-05956

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Haiying Cheng, Principal Investigator, Albert Einstein College of Medicine EDDOP


Verification Date

July 2021